Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
monitor, breathing frequency
Product Code
BZQ
Regulation Number
868.2375
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAXTER HEALTHCARE CORPRORATION
SUBSTANTIALLY EQUIVALENT
1
BIANCAMED LIMITED
SUBSTANTIALLY EQUIVALENT
1
CIRCADIA TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
1. K111933
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICA
...
EARLYSENSE LTD.
SUBSTANTIALLY EQUIVALENT
7
HILL-ROM INC.
SUBSTANTIALLY EQUIVALENT
1
HILL-ROM, INC.
SUBSTANTIALLY EQUIVALENT
1
KAI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
KAI SENSORS, INC
SUBSTANTIALLY EQUIVALENT
1
LINSHOM MANAGEMENT LLC
SUBSTANTIALLY EQUIVALENT
1
LINSHOM MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NEUROVISION MEDICAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
SUBSTANTIALLY EQUIVALENT
1
PMD SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
PNEUMACARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
RESPIREE PTE LTD.
SUBSTANTIALLY EQUIVALENT
1
SALTER LABS
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN FIBER MEDICAL TECHNOLOGY CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
SOUND LIFE SCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
1
TURTLE SHELL TECHNOLOGIES PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
11
11
2018
10
10
2019
13
13
2020
10
10
2021
1
1
2022
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Alarm System
7
7
Defective Component
6
6
Device Fell
3
3
Therapeutic or Diagnostic Output Failure
3
3
No Audible Alarm
3
3
Device Operates Differently Than Expected
3
3
Device Inoperable
3
3
Inaudible or Unclear Audible Prompt/Feedback
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Displays Incorrect Message
2
2
Display or Visual Feedback Problem
2
2
No Device Output
2
2
Operating System Becomes Nonfunctional
1
1
No Display/Image
1
1
Output Problem
1
1
Mechanical Problem
1
1
Communication or Transmission Problem
1
1
Break
1
1
Wireless Communication Problem
1
1
Insufficient Information
1
1
Defective Device
1
1
Alarm Not Visible
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Delayed Alarm
1
1
Computer Operating System Problem
1
1
Incorrect Measurement
1
1
Application Network Problem
1
1
Device Stops Intermittently
1
1
Loss of Data
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
26
26
No Patient Involvement
7
7
Death
5
5
No Clinical Signs, Symptoms or Conditions
5
5
Complaint, Ill-Defined
1
1
Cardiopulmonary Arrest
1
1
Tachycardia
1
1
Sore Throat
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Salter Laboratories, Division of Regulatory Affairs
II
Feb-03-2011
-
-