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 |