O-Two Systems Intl., Inc.
Walker, MI, US
O-Two Systems Intl., Inc. appears in FDA device records in Walker, MI. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for O-Two Systems Intl., Inc. between 1983 and 1999. The busiest year on record is 1998, with 4. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 2 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1997 | 1 |
| 1998 | 4 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991195 | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV | BTL | Substantially Equivalent | |
| K983857 | AUTOVENT 1500 | BTL | Substantially Equivalent | |
| K983785 | AUTOVENT 1000 | BTL | Substantially Equivalent | |
| K983705 | EMT RESUSCITATOR | BTL | Substantially Equivalent | |
| K983643 | GENESIS BLS | BTL | Substantially Equivalent | |
| K960995 | CPR BIO-BARRIER FACESHEILD | CBP | Substantially Equivalent | |
| K940712 | PPM III | CBP | Substantially Equivalent | |
| K940927 | RESCUE BREATHER | CBP | Substantially Equivalent | |
| K932170 | FLYNNR GENESIS II A/C, A/O AND IDLH | BTL | Substantially Equivalent | |
| K922810 | ODYSSEY | BTM | Substantially Equivalent | |
| K913039 | FLLYNN(R) GENESIS AC | BTL | Substantially Equivalent | |
| K841429 | MOUTH TO MASK EMERGENCY VENTILATION | CAE | Substantially Equivalent | |
| K834400 | FLYNN III-CHILD BAG-MASK UNIT ETC | BTM | Substantially Equivalent | |
| K832495 | FLYNN SERIES III BAG/MASK UNIT- | BTM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain