The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Phonic Ear, Model Pe 1800.
| Device ID | K862162 |
| 510k Number | K862162 |
| Device Name: | PHONIC EAR, MODEL PE 1800 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| 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 | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-06 |
| Decision Date | 1986-07-18 |