Company ยท CA
O-Two Systems Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1999. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 22, 1999 | K991195 | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV O-Two Systems Intl., Inc., CA | BTL |
| Nov 4, 1998 | K983857 | AUTOVENT 1500 O-Two Systems Intl., Inc., CA | BTL |
| Oct 29, 1998 | K983785 | AUTOVENT 1000 O-Two Systems Intl., Inc., CA | BTL |
| Oct 29, 1998 | K983705 | EMT RESUSCITATOR O-Two Systems Intl., Inc., CA | BTL |
| Oct 29, 1998 | K983643 | GENESIS BLS O-Two Systems Intl., Inc., CA | BTL |
| Jan 7, 1997 | K960995 | CPR BIO-BARRIER FACESHEILD O-Two Systems Intl., Inc., CA | CBP |
| Nov 14, 1994 | K940712 | PPM III O-Two Systems Intl., Inc., CA | CBP |
| Oct 14, 1994 | K940927 | RESCUE BREATHER O-Two Systems Intl., Inc., CA | CBP |
| Oct 25, 1993 | K932170 | FLYNNR GENESIS II A/C, A/O AND IDLH O-Two Systems Intl., Inc., CA | BTL |
| Jan 22, 1993 | K922810 | ODYSSEY O-Two Systems Intl., Inc., CA | BTM |
| Aug 25, 1992 | K913039 | FLLYNN(R) GENESIS AC O-Two Systems Intl., Inc., CA | BTL |
| Apr 17, 1984 | K841429 | MOUTH TO MASK EMERGENCY VENTILATION O-Two Systems Intl., Inc. | CAE |
| Jan 13, 1984 | K834400 | FLYNN III-CHILD BAG-MASK UNIT ETC O-Two Systems Intl., Inc. | BTM |
| Sep 29, 1983 | K832495 | FLYNN SERIES III BAG/MASK UNIT- O-Two Systems Intl., Inc. | BTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||