The following data is part of a premarket notification filed by Harmony Hearing Aids, Co. with the FDA for Harmony Hearing Aid Models Lp, M, Ho, Hf, & C.
| Device ID | K882005 |
| 510k Number | K882005 |
| Device Name: | HARMONY HEARING AID MODELS LP, M, HO, HF, & C |
| Classification | Hearing Aid, Air Conduction |
| Applicant | HARMONY HEARING AIDS, CO. 9425 OLDE EIGHT RD. Northfield Center, OH 44067 |
| Contact | Gerald A Bloch |
| Correspondent | Gerald A Bloch HARMONY HEARING AIDS, CO. 9425 OLDE EIGHT RD. Northfield Center, OH 44067 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-13 |
| Decision Date | 1988-07-12 |