Medical Device Manufacturer · US , Walker , MI

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

14 submissions · 14 cleared · Since 1983

Total

Cleared

Denied

O-Two Systems Intl., Inc. has 14 FDA 510(k) cleared anesthesiology devices. Based in Walker, US.

Historical record: 14 cleared submissions from 1983 to 1999.

Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

14 devices

1-14 of 14

Cleared Apr 22, 1999

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

CPR BIO-BARRIER FACESHEILD

K960995 · CBP

Anesthesiology · 301d

Cleared Nov 14, 1994

PPM III

K940712 · CBP

Anesthesiology · 270d

Cleared Oct 14, 1994

RESCUE BREATHER

K940927 · CBP

Anesthesiology · 228d

Cleared Oct 25, 1993

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

K932170 · BTL

Anesthesiology · 174d

Cleared Jan 22, 1993

ODYSSEY

K922810 · BTM

Anesthesiology · 226d

Cleared Aug 25, 1992

FLLYNN(R) GENESIS AC

K913039 · BTL

Anesthesiology · 413d

Cleared Apr 17, 1984

MOUTH TO MASK EMERGENCY VENTILATION

K841429 · CAE

Anesthesiology · 11d

Cleared Jan 13, 1984

FLYNN III-CHILD BAG-MASK UNIT ETC

K834400 · BTM

Anesthesiology · 30d

Cleared Sep 29, 1983

FLYNN SERIES III BAG/MASK UNIT-

K832495 · BTM

Anesthesiology · 64d

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

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