The following data is part of a premarket notification filed by Diagnostic Group Llc with the FDA for Ma61, Ma62, Ma63 Family Of Portable Audiometers.
| Device ID | K092244 |
| 510k Number | K092244 |
| Device Name: | MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS |
| Classification | Audiometer |
| Applicant | DIAGNOSTIC GROUP LLC 7625 GOLDEN TRIANGLE DR. Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan DIAGNOSTIC GROUP LLC 7625 GOLDEN TRIANGLE DR. 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 | 2009-07-28 |
| Decision Date | 2010-03-01 |