510(k) K900819

BLOOD GAS CALIBRATION STANDARD by Cryogenic Rare Gas Laboratories, Inc. — Product Code LCH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
February 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type