Medical Device Manufacturer · US , Walker , MI

O-Two Systems Intl., Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1983

Recent clearances: CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV, AUTOVENT 1500, GENESIS BLS

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - O-Two Systems Intl., Inc. Anesthesiology ✕

14 devices

1-14 of 14

Cleared Apr 22, 1999

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

Anesthesiology · 14d

Cleared Nov 04, 1998

Anesthesiology · 2d

Cleared Oct 29, 1998

Anesthesiology · 13d

Cleared Oct 29, 1998

EMT RESUSCITATOR

Anesthesiology · 8d

Cleared Oct 29, 1998

Anesthesiology · 2d

Cleared Jan 07, 1997

CPR BIO-BARRIER FACESHEILD

Anesthesiology · 301d

Cleared Nov 14, 1994

Anesthesiology · 270d

Cleared Oct 14, 1994

RESCUE BREATHER

Anesthesiology · 228d

Cleared Oct 25, 1993

FLYNNR GENESIS II A/C, A/O AND IDLH

Anesthesiology · 174d

Cleared Jan 22, 1993

Anesthesiology · 226d

Cleared Aug 25, 1992

FLLYNN(R) GENESIS AC

Anesthesiology · 413d

Cleared Apr 17, 1984

MOUTH TO MASK EMERGENCY VENTILATION

Anesthesiology · 11d

Cleared Jan 13, 1984

FLYNN III-CHILD BAG-MASK UNIT ETC

Anesthesiology · 30d

Cleared Sep 29, 1983

FLYNN SERIES III BAG/MASK UNIT-

Anesthesiology · 64d