Cleared Traditional

LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA

K781454 · Union Carbide Corp. · Chemistry
Sep 1978
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K781454 is an FDA 510(k) clearance for the LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA, a Titrimetric With Edta And Indicator, Calcium (Class II — Special Controls, product code CHW), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978, 29 days after receiving the submission on August 22, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K781454 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1978
Decision Date September 20, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHW — Titrimetric With Edta And Indicator, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145