510(k) K800224

RADIOMETER ACID BASE LABORATORY-ABL-3 by The London Co. — Product Code CHL

K800224 is an FDA 510(k) premarket notification submitted by The London Co. for the device "RADIOMETER ACID BASE LABORATORY-ABL-3". The FDA issued a decision of Substantially Equivalent on February 22, 1980. 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. The London Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1980
Date Received
February 5, 1980
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