ODYSSEY

Ventilator, Emergency, Manual (resuscitator)

O-TWO SYSTEMS INTL., INC.

The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Odyssey.

Pre-market Notification Details

• Device ID: K922810
• 510k Number: K922810
• Device Name: ODYSSEY
• Classification: Ventilator, Emergency, Manual (resuscitator)
• Applicant: O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8
• Contact: Kevin Bowden
• Correspondent: Kevin Bowden; O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8
• Product Code: BTM
• CFR Regulation Number: 868.5915 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-06-10
• Decision Date: 1993-01-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07540195020115	K922810	000
07540195020016	K922810	000