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 K954731
Device Name OXYLOG 2
Applicant
P.K. MORGAN LTD.
4 BLOORS LANE
KENT RAINHAM ME8 7ED,  GB
Applicant Contact R. H KERNAGHAN
Correspondent
P.K. MORGAN LTD.
4 BLOORS LANE
KENT RAINHAM ME8 7ED,  GB
Correspondent Contact R. H KERNAGHAN
Regulation Number868.1730
Classification Product Code
BZL  
Date Received10/16/1995
Decision Date 01/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-