The following data is part of a premarket notification filed by Magnatone Hearing Aid Corp. with the FDA for Magnatone / Sterling/ St; Magnatone/db; Magnatone/ Liberty/ Lb; Magnatone/ Pearl/ph C.i.c., S.p.i., One Touch, Designer.
| Device ID | K973665 |
| 510k Number | K973665 |
| Device Name: | MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MAGNATONE HEARING AID CORP. 170 N. CYPRESS WAY P.O. BOX 180964 Casselberry, FL 32718 -0964 |
| Contact | Don E Campbell |
| Correspondent | Don E Campbell 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 | 1997-09-25 |
| Decision Date | 1997-11-04 |