The following data is part of a premarket notification filed by Magnatone Hearing Aid Corp. with the FDA for Nhs 2044p Body Aid, Hearing Aid.
| Device ID | K911183 |
| 510k Number | K911183 |
| Device Name: | NHS 2044P BODY AID, HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MAGNATONE HEARING AID CORP. 170 N. CYPRESS WAY P.O. BOX 180964 Casselberry, FL 32718 -0964 |
| Contact | Tony Quick |
| Correspondent | Tony Quick MAGNATONE HEARING AID CORP. 170 N. CYPRESS WAY P.O. BOX 180964 Casselberry, FL 32718 -0964 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-18 |
| Decision Date | 1991-07-09 |