The following data is part of a premarket notification filed by Maico Diagnostic Gmbh with the FDA for Mb 11.
| Device ID | K011746 |
| 510k Number | K011746 |
| Device Name: | MB 11 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | MAICO DIAGNOSTIC GMBH 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Daniel E Eggan |
| Correspondent | Daniel E Eggan MAICO DIAGNOSTIC GMBH 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-06 |
| Decision Date | 2001-08-24 |