510(k) K944089

AVL OPTI PH/BLOOD GAS ANALYZER by Avl Scientific Corp. — Product Code CHL

K944089 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL OPTI PH/BLOOD GAS ANALYZER". The FDA issued a decision of Substantially Equivalent on October 20, 1994. 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. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
August 22, 1994
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