The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Phonic Ear.
| Device ID | K861857 |
| 510k Number | K861857 |
| Device Name: | PHONIC EAR |
| 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 | 1986-05-14 |
| Decision Date | 1986-06-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PHONIC EAR 79092060 4069213 Live/Registered |
Phonic Ear A/S 2010-08-27 |
![]() PHONIC EAR 74734046 2009958 Live/Registered |
PHONIC EAR A/S 1995-09-22 |
![]() PHONIC EAR 72255884 0850192 Live/Registered |
H C ELECTRONICS, INC. 1966-10-06 |