The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Tympanometer.
| Device ID | K861516 |
| 510k Number | K861516 |
| Device Name: | WELCH ALLYN TYMPANOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Robert W Becker |
| Correspondent | Robert W Becker WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-23 |
| Decision Date | 1986-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094144840 | K861516 | 000 |
| 00732094048414 | K861516 | 000 |
| 00732094048407 | K861516 | 000 |
| 00732094048193 | K861516 | 000 |
| 00732094048186 | K861516 | 000 |
| 00732094301069 | K861516 | 000 |
| 00732094300659 | K861516 | 000 |
| 00732094300642 | K861516 | 000 |
| 00732094084733 | K861516 | 000 |
| 00732094084726 | K861516 | 000 |
| 00732094084719 | K861516 | 000 |
| 00732094084702 | K861516 | 000 |
| 00732094084597 | K861516 | 000 |
| 00732094084580 | K861516 | 000 |
| 00732094048421 | K861516 | 000 |
| 00732094048438 | K861516 | 000 |
| 00732094140507 | K861516 | 000 |
| 00732094140484 | K861516 | 000 |
| 00732094084566 | K861516 | 000 |
| 00732094084559 | K861516 | 000 |
| 00732094084542 | K861516 | 000 |
| 00732094083712 | K861516 | 000 |
| 00732094083705 | K861516 | 000 |
| 00732094083491 | K861516 | 000 |
| 00732094083484 | K861516 | 000 |
| 00732094083477 | K861516 | 000 |
| 00732094083460 | K861516 | 000 |
| 00732094082319 | K861516 | 000 |
| 00732094082036 | K861516 | 000 |
| 00732094082760 | K861516 | 000 |