The following data is part of a premarket notification filed by Maico Diagnostics (diagnostic Group Llc) with the FDA for Ma 55 Maestro.
| Device ID | K063452 |
| 510k Number | K063452 |
| Device Name: | MA 55 MAESTRO |
| Classification | Audiometer |
| Applicant | MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC) 7625 GOLDEN TRIANGLE D Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC) 7625 GOLDEN TRIANGLE D Eden Prairie, MN 55344 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2007-03-29 |