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 Ventilator, Continuous, Facility Use
510(k) Number K922975
Device Name MODEL 7200AE VENTILATOR (ENHANCEMENT)
Applicant
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact MARK JENSEN
Correspondent
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact MARK JENSEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/22/1992
Decision Date 09/22/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-