|
Device |
analyzer, gas, carbon-dioxide, gaseous-phase |
Product Code | CCK |
Regulation Number |
868.1400
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABEON MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K131506 AIRWAY SUPPORT SYSTEM / AIRPORT
|
2. K142467 IntelAir Nasal Airway Support System
|
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BESMED HEALTH BUSINESS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLUEPOINT MEDICAL GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CMI HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DISPO-MED (MALAYSIA) SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAEGER MEDICAL AG & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAEGERWERK AG & CO. KGAA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDURE INDUSTRIES INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENGINEERED MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLEXICARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLEXICARE MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE HEALTHCARE FINLAND OY |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INTERSURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MASIMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXTEC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXTEC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIPINES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIPLUS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERCURY MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MONITOR MASK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIHON KOHDEN AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIHON KOHDEN CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NIHON KOHDEN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORANTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORIDION CAPNOGRAPHY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORIDION MEDICAL 1987 LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
PHASEIN AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PNEUMA THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POM MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESPIRION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REVOLUTIONARY MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SALTER LABS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEEBREATH AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHMEDIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHMEDIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPACELABS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TELEFLEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TYLENOL MEDICAL INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMED MEDICAL SUPPLIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTLAB CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTURE THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYAIRE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WESTMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
CareFusion 303, Inc. |
II |
Aug-30-2019 |
2 |
CareFusion 303, Inc. |
II |
Dec-21-2015 |
3 |
Covidien Limited |
I |
Sep-08-2009 |
4 |
Covidien Llc |
II |
Dec-01-2020 |
5 |
GE Healthcare, LLC |
I |
Jan-10-2020 |
6 |
GE Healthcare, LLC |
I |
Jul-18-2014 |
7 |
Medtronic |
I |
May-12-2016 |
8 |
Oridion Medical 1987 Ltd. |
II |
Oct-03-2018 |
9 |
Oridion Medical 1987 Ltd. |
II |
Mar-30-2012 |
10 |
Oridion Medical 1987 Ltd. |
II |
Mar-29-2012 |
11 |
Oridion Medical 1987 Ltd. |
I |
May-25-2011 |
12 |
Oridion Medical 1987 Ltd. |
II |
Jul-13-2010 |
13 |
Oridion Medical 1987 Ltd. |
II |
Sep-21-2009 |
14 |
Philips Healthcare Inc. |
I |
May-26-2011 |
15 |
Philips Healthcare Inc. |
II |
Apr-08-2010 |
16 |
SALTER LABS |
II |
Nov-19-2013 |
17 |
SALTER LABS |
II |
Jun-27-2012 |
18 |
SALTER LABS |
II |
Jan-11-2012 |
19 |
Salter Laboratories, Division of Regulatory Affairs |
II |
May-23-2011 |
20 |
Salter Laboratories, Division of Regulatory Affairs |
II |
May-20-2011 |
21 |
Smiths Medical ASD Inc. |
II |
Jul-06-2018 |
22 |
Smiths Medical ASD, Inc. |
II |
May-29-2015 |
23 |
Smiths Medical ASD, Inc. |
I |
Mar-29-2013 |
24 |
Smiths Medical PM, Inc. |
II |
Mar-02-2010 |
25 |
Smiths Medical PM, Inc. |
II |
May-15-2009 |
26 |
Southmedic, Inc. |
II |
Jul-24-2021 |
27 |
Southmedic, Inc. |
II |
Jan-25-2018 |
28 |
Ventlab LLC |
II |
Jun-01-2016 |
|
|
|
|