510(k) K801599

CORNING 184 BLOOD GAS TONOMETER by Corning Medical & Scientific — Product Code LCH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 14, 1980
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