• 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, emergency, manual (resuscitator)
510(k) Number K881483
Device Name AIRWAY-CIRCULATION EVALUATOR
Applicant
RESUSCITATION ACE, INC.
3965 PINEHURST CIRCLE
DENVER,  CO  80235
Applicant Contact CHARLES M ABERNATHY
Correspondent
RESUSCITATION ACE, INC.
3965 PINEHURST CIRCLE
DENVER,  CO  80235
Correspondent Contact CHARLES M ABERNATHY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/08/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-