The following data is part of a premarket notification filed by Phonic Ear, Inc. with the FDA for Phonic Ear.
Device ID | K830098 |
510k Number | K830098 |
Device Name: | PHONIC EAR |
Classification | Hearing Aid, Air Conduction |
Applicant | PHONIC EAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-11 |
Decision Date | 1983-02-01 |
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 |