Cleared Traditional

MONITOR, GAS MANIFOLD

K770614 · Dynatech Cryomedical Co. · Anesthesiology
Apr 1977
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K770614 is an FDA 510(k) clearance for the MONITOR, GAS MANIFOLD, a Gauge, Gas Pressure, Cylinder/pipeline (Class I — General Controls, product code BXH), submitted by Dynatech Cryomedical Co. (Walker, US). The FDA issued a Cleared decision on April 7, 1977, 7 days after receiving the submission on March 31, 1977. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2610.

Submission Details

510(k) Number K770614 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1977
Decision Date April 07, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BXH — Gauge, Gas Pressure, Cylinder/pipeline
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2610