The following data is part of a premarket notification filed by Fogless International Ab with the FDA for Spiro Speaking Valve With Oxygen Port Spiro Speaking Valve Without Oxygen Port.
| Device ID | K122932 |
| 510k Number | K122932 |
| Device Name: | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | FOGLESS INTERNATIONAL AB STORGATAN 24 Vaggeryd, SE 56732 |
| Contact | Jason Walton |
| Correspondent | Jason Walton FOGLESS INTERNATIONAL AB STORGATAN 24 Vaggeryd, SE 56732 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2013-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350061231350 | K122932 | 000 |
| 07350061231268 | K122932 | 000 |
| 07350061231237 | K122932 | 000 |
| 07350061231183 | K122932 | 000 |
| 07350061231152 | K122932 | 000 |
| 07350061231121 | K122932 | 000 |
| 07350061231114 | K122932 | 000 |
| 07350061231091 | K122932 | 000 |
| 07350061230353 | K122932 | 000 |