The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Tympovent.
| Device ID | K936275 |
| 510k Number | K936275 |
| Device Name: | TYMPOVENT |
| Classification | Tube, Tympanostomy |
| Applicant | ATOS MEDICAL AB P.O. BOX 183 Horby, Sweden, SE Se-24222 |
| Contact | Karl-erik Karlson |
| Correspondent | Karl-erik Karlson ATOS MEDICAL AB P.O. BOX 183 Horby, Sweden, SE Se-24222 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-05-05 |