The following data is part of a premarket notification filed by Maico Diagnostics with the FDA for Maico Mb 11 With Beraphone Probe.
| Device ID | K082035 |
| 510k Number | K082035 |
| Device Name: | MAICO MB 11 WITH BERAPHONE PROBE |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | MAICO DIAGNOSTICS 7625 GOLDEN TRIANGLE DR. Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan MAICO DIAGNOSTICS 7625 GOLDEN TRIANGLE DR. 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 | 2008-07-17 |
| Decision Date | 2009-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260176120520 | K082035 | 000 |
| 04260176120513 | K082035 | 000 |