Cleared Traditional

K936046 - SIGMA ELITE
(FDA 510(k) Clearance)

K936046 · Penlon, Inc. · Anesthesiology

Nov 1994

Decision

319d

Days

Class 2

Risk

K936046 is an FDA 510(k) clearance for the SIGMA ELITE. This device is classified as a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD).

Submitted by Penlon, Inc. (Abingdon Ox, GB). The FDA issued a Cleared decision on November 4, 1994, 319 days after receiving the submission on December 20, 1993.

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

Submission Details

510(k) Number	K936046 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 1993
Decision Date	November 04, 1994
Days to Decision	319 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF