The following data is part of a premarket notification filed by Ototech Intl., Inc. with the FDA for Model Alpha Behind-the-ear Hearing Instrument.
Device ID | K962228 |
510k Number | K962228 |
Device Name: | MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT |
Classification | Hearing Aid, Air Conduction |
Applicant | OTOTECH INTL., INC. 3400 N.W. 56TH Oklahoma City, OK 73112 |
Contact | David A Hough |
Correspondent | David A Hough OTOTECH INTL., INC. 3400 N.W. 56TH Oklahoma City, OK 73112 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-10 |
Decision Date | 1996-08-28 |
Summary: | summary |