Cleared Traditional

K760969 - PH/BLOOD GAS SYSTEM (FDA 510(k) Clearance)

K760969 · Instrumentation Laboratory CO · Chemistry device
Jan 1977
Decision
69d
Days
Class 2
Risk

K760969 is an FDA 510(k) clearance for the PH/BLOOD GAS SYSTEM. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on January 12, 1977, 69 days after receiving the submission on November 4, 1976.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K760969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1976
Decision Date January 12, 1977
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.1120