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 Computer, Oxygen-Uptake
510(k) Number K874663
Device Name MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
Applicant
Ametek/Thermox Instruments Division
150 Freeport Rd.
Pittsburgh,  PA  15238
Applicant Contact RICHARD W WANEK
Correspondent
Ametek/Thermox Instruments Division
150 Freeport Rd.
Pittsburgh,  PA  15238
Correspondent Contact RICHARD W WANEK
Regulation Number868.1730
Classification Product Code
BZL  
Date Received11/13/1987
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-