Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back To Search Results
Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K895747
Device Name VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
Applicant
HUDSON OXYGEN THERAPY SALES CO.
27711 DIAZ ST.
P.O. BOX 66
TEMECULA,  CA  92390
Applicant Contact JORGE HAIDER
Correspondent
HUDSON OXYGEN THERAPY SALES CO.
27711 DIAZ ST.
P.O. BOX 66
TEMECULA,  CA  92390
Correspondent Contact JORGE HAIDER
Regulation Number868.2600
Classification Product Code
CAP  
Date Received09/26/1989
Decision Date 10/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-