Cleared Traditional

K841733 - OHIO WASTE GAS SCAVENGING RESERVOIR (FDA 510(k) Clearance)

Jul 1984
Decision
76d
Days
Class 2
Risk

K841733 is an FDA 510(k) clearance for the OHIO WASTE GAS SCAVENGING RESERVOIR. This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on July 11, 1984, 76 days after receiving the submission on April 26, 1984.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number K841733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1984
Decision Date July 11, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CBN — Apparatus, Gas-scavenging
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5430