SIGMA ELITE

Vaporizer, Anesthesia, Non-heated

PENLON, INC.

The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Sigma Elite.

Pre-market Notification Details

• Device ID: K936046
• 510k Number: K936046
• Device Name: SIGMA ELITE
• Classification: Vaporizer, Anesthesia, Non-heated
• Applicant: PENLON, INC. ABINGDON OX14 3PH England, GB
• Contact: G.i. Wond
• Correspondent: G.i. Wond; PENLON, INC. ABINGDON OX14 3PH England, GB
• Product Code: CAD
• CFR Regulation Number: 868.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-12-20
• Decision Date: 1994-11-04