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, emergency, manual (resuscitator)
510(k) Number K912625
Device Name MOUTH TO MASK RESUSCITATOR
Applicant
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Applicant Contact ALBERTO VELEZ
Correspondent
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Correspondent Contact ALBERTO VELEZ
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/13/1991
Decision Date 08/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-