ADVANTAGE

Ventilator, Non-continuous (respirator)

STEVENSON INDUSTRIES, INC.

The following data is part of a premarket notification filed by Stevenson Industries, Inc. with the FDA for Advantage.

Pre-market Notification Details

• Device ID: K141152
• 510k Number: K141152
• Device Name: ADVANTAGE
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: STEVENSON INDUSTRIES, INC. 780 CHAMBERS LANE SUITE 200 Simi Valley, CA 93065
• Contact: Serrah Namini
• Correspondent: Serrah Namini; STEVENSON INDUSTRIES, INC. 780 CHAMBERS LANE SUITE 200 Simi Valley, CA 93065
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-05
• Decision Date: 2014-10-17
• Summary: summary