The following data is part of a premarket notification filed by Emtech Laboratories with the FDA for Oe Series Of Behind-the-ear Hearing Aids.
| Device ID | K853381 |
| 510k Number | K853381 |
| Device Name: | OE SERIES OF BEHIND-THE-EAR HEARING AIDS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | EMTECH LABORATORIES P.O. BOX 12900 Roanoke, VA 24022 |
| Contact | Jerry Agnew |
| Correspondent | Jerry Agnew EMTECH LABORATORIES P.O. BOX 12900 Roanoke, VA 24022 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-11-08 |