The following data is part of a premarket notification filed by Anm Adaptive Neuromodulation Gmbh with the FDA for Tinnitus Therapy System Anm T30 Cr.
| Device ID | K112752 |
| 510k Number | K112752 |
| Device Name: | TINNITUS THERAPY SYSTEM ANM T30 CR |
| Classification | Masker, Tinnitus |
| Applicant | ANM ADAPTIVE NEUROMODULATION GMBH IM MEDIAPARK 6D Koln, DE D-50670 |
| Contact | Ingrid Rohm |
| Correspondent | Ingrid Rohm ANM ADAPTIVE NEUROMODULATION GMBH IM MEDIAPARK 6D Koln, DE D-50670 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-21 |
| Decision Date | 2011-12-16 |
| Summary: | summary |