The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for System 22 Valve.
| Device ID | K950397 |
| 510k Number | K950397 |
| Device Name: | SYSTEM 22 VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-01 |
| Decision Date | 1995-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884838083319 | K950397 | 000 |
| 30884838083227 | K950397 | 000 |
| 30884838083234 | K950397 | 000 |
| 30884838083241 | K950397 | 000 |
| 30884838083258 | K950397 | 000 |
| 30884838083265 | K950397 | 000 |
| 30884838083272 | K950397 | 000 |
| 30884838083289 | K950397 | 000 |
| 30884838083296 | K950397 | 000 |
| 30884838083302 | K950397 | 000 |
| 30884838083210 | K950397 | 000 |