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 mask, oxygen
510(k) Number K945482
Device Name DISPOSABLE, CPAP OXYGEN MASK
Applicant
FVTNKS
67920 KLINGER LAKE RD.
STURGIS,  MI  49091 -9288
Applicant Contact PAUL E DRYDEN
Correspondent
FVTNKS
67920 KLINGER LAKE RD.
STURGIS,  MI  49091 -9288
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5580
Classification Product Code
BYG  
Date Received11/08/1994
Decision Date 09/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-