510(k) K781454

LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA by Union Carbide Corp. — Product Code CHW

K781454 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA". The FDA issued a decision of Substantially Equivalent on September 20, 1978. The device falls under product code CHW (Titrimetric With Edta And Indicator, Calcium), a Class II device regulated under 21 CFR 862.1145. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1978
Date Received
August 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Titrimetric With Edta And Indicator, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type