The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Post-auricular Hearing Aid Model Pe 600ppcl.
| Device ID | K844861 |
| 510k Number | K844861 |
| Device Name: | POST-AURICULAR HEARING AID MODEL PE 600PPCL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | PHONIC EAR, INC. 250 CAMINO ALTO Mill Valley, CA 94941 |
| Contact | Robert L Reinke |
| Correspondent | Robert L Reinke PHONIC EAR, INC. 250 CAMINO ALTO Mill Valley, CA 94941 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-14 |
| Decision Date | 1985-03-27 |