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 Oximeter
510(k) Number K931304
Device Name OHMEDA HAND HELD OXIMETER
Applicant
Ohmeda Medical
1315 W. Louisville Dr.
Louisville,  CO  80027
Applicant Contact KEVIN MORNINGSTAR
Correspondent
Ohmeda Medical
1315 W. Louisville Dr.
Louisville,  CO  80027
Correspondent Contact KEVIN MORNINGSTAR
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/15/1993
Decision Date 09/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-