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 Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K901548
Device Name BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact ABATI, PHD
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact ABATI, PHD
Regulation Number868.1150
Classification Product Code
CCC  
Date Received04/03/1990
Decision Date 01/14/1991
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
-
-