CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV

Ventilator, Emergency, Powered (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 Carevent Bls, Carevent Bls+, Carevent Als, Carevent Als+, And Carevent Atv.

Pre-market Notification Details

• Device ID: K991195
• 510k Number: K991195
• Device Name: CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
• Classification: Ventilator, Emergency, Powered (resuscitator)
• Applicant: O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST., UNIT 5 MISSISSAUGA Ontario L5s 1c8, CA
• Contact: Kevin Bowden
• Correspondent: Kevin Bowden; O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST., UNIT 5 MISSISSAUGA Ontario L5s 1c8, CA
• Product Code: BTL
• CFR Regulation Number: 868.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-08
• Decision Date: 1999-04-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07540195025325	K991195	000
07540195025295	K991195	000
07540195025165	K991195	000
07540195025127	K991195	000
07540195025110	K991195	000