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O-Two Systems Intl., Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K991195 CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATVBTL1999-04-22 View
510(k) K983857 AUTOVENT 1500BTL1998-11-04 View
510(k) K983785 AUTOVENT 1000BTL1998-10-29 View
510(k) K983643 GENESIS BLSBTL1998-10-29 View
510(k) K983705 EMT RESUSCITATORBTL1998-10-29 View
510(k) K960995 CPR BIO-BARRIER FACESHEILDCBP1997-01-07 View
510(k) K940712 PPM IIICBP1994-11-14 View
510(k) K940927 RESCUE BREATHERCBP1994-10-14 View
510(k) K932170 FLYNNR GENESIS II A/C, A/O AND IDLHBTL1993-10-25 View
510(k) K922810 ODYSSEYBTM1993-01-22 View
510(k) K913039 FLLYNN(R) GENESIS ACBTL1992-08-25 View
510(k) K841429 MOUTH TO MASK EMERGENCY VENTILATIONCAE1984-04-17 View
510(k) K834400 FLYNN III-CHILD BAG-MASK UNIT ETCBTM1984-01-13 View
510(k) K832495 FLYNN SERIES III BAG/MASK UNIT-BTM1983-09-29 View
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