510(k) K882209

MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES by Linde Div. Union Carbide Corp. — Product Code CHL

K882209 is an FDA 510(k) premarket notification submitted by Linde Div. Union Carbide Corp. for the device "MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES". The FDA issued a decision of Substantially Equivalent on August 2, 1988. 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. Linde Div. Union Carbide Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1988
Date Received
May 26, 1988
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