510(k) K770494

BLOOD GAS ANALYZER-CALIBRATION GAS by Gardner Cryogenics — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
March 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type