Cleared Traditional

O2 CONNECTOR

K780750 · Diemolding Corp. · Anesthesiology
Jul 1978
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K780750 is an FDA 510(k) clearance for the O2 CONNECTOR, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978, 80 days after receiving the submission on May 8, 1978. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number K780750 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1978
Decision Date July 27, 1978
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CAN — Regulator, Pressure, Gas Cylinder
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2700

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