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 valve, non-rebreathing
510(k) Number K955520
Device Name RESCUE BREATHER
Applicant
INTERNATIONAL SAFETY, INC.
2322 DOUGLAS DR.
EUGENE,  OR  97405
Applicant Contact ROBERT S MCQUATE
Correspondent
INTERNATIONAL SAFETY, INC.
2322 DOUGLAS DR.
EUGENE,  OR  97405
Correspondent Contact ROBERT S MCQUATE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received12/04/1995
Decision Date 10/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-