The following data is part of a premarket notification filed by Pascal Medical Ab with the FDA for Pascal Medical Ab Meniett 20.
| Device ID | K991562 |
| 510k Number | K991562 |
| Device Name: | PASCAL MEDICAL AB MENIETT 20 |
| Classification | Tester, Auditory Impedance |
| Applicant | PASCAL MEDICAL AB 7307 GLOUCHESTER DR. Minneapolis, MN 55435 |
| Contact | Jeffrey R Sideman |
| Correspondent | Jeffrey R Sideman PASCAL MEDICAL AB 7307 GLOUCHESTER DR. Minneapolis, MN 55435 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-04 |
| Decision Date | 1999-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885074415400 | K991562 | 000 |
| 00721902326257 | K991562 | 000 |
| 00721902326264 | K991562 | 000 |
| 00721902326271 | K991562 | 000 |
| 00721902541094 | K991562 | 000 |
| 00721902935220 | K991562 | 000 |
| 00643169576476 | K991562 | 000 |
| 00643169344938 | K991562 | 000 |
| 00885074138688 | K991562 | 000 |
| 20885074415356 | K991562 | 000 |
| 20885074415363 | K991562 | 000 |
| 20885074415370 | K991562 | 000 |
| 20885074415387 | K991562 | 000 |
| 20885074415394 | K991562 | 000 |
| 00721902265846 | K991562 | 000 |