Cleared Traditional

K843993 - ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 (FDA 510(k) Clearance)

Nov 1984
Decision
35d
Days
Class 2
Risk

K843993 is an FDA 510(k) clearance for the ANAESLOCK THREE VAPORIZER INTERLOCK HVA003. This device is classified as a Vaporizer, Anesthesia, Non-heated (Class II - Special Controls, product code CAD).

Submitted by Southmedic, Inc. (Ancaster, Ontario, CA). The FDA issued a Cleared decision on November 15, 1984, 35 days after receiving the submission on October 11, 1984.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K843993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date November 15, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -

Device Classification

Product Code CAD - Vaporizer, Anesthesia, Non-heated
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5880