The following data is part of a premarket notification filed by Maxi-aids, Inc. with the FDA for Hf Mega Ear.
| Device ID | K960567 |
| 510k Number | K960567 |
| Device Name: | HF MEGA EAR |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | MAXI-AIDS, INC. 42 EXECUTIVE BLVD. Farmingdale, NY 11735 |
| Contact | Harris Boshak |
| Correspondent | Harris Boshak MAXI-AIDS, INC. 42 EXECUTIVE BLVD. Farmingdale, NY 11735 |
| Product Code | EPF |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-09 |
| Decision Date | 1996-10-16 |