510(k) K833534

PARTIAL PRESSURE ELECTRODE MEASUREMENT by Shaban Mfg. Co. — Product Code CHL

K833534 is an FDA 510(k) premarket notification submitted by Shaban Mfg. Co. for the device "PARTIAL PRESSURE ELECTRODE MEASUREMENT". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Shaban Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
September 27, 1983
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