510(k) K844781

MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB by Shaban Mfg. Co. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1985
Date Received
December 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type