FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48— 510(k) K973861
Substantially EquivalentMagnatone Hearing Aid Corp.
FDA 510(k) clearance K973861 for FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48, Substantially Equivalent on 1997-11-19. Applicant: Magnatone Hearing Aid Corp.. Device class: 1.
Clearance details
- Applicant
- Magnatone Hearing Aid Corp.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Casselberry, FL, US
Recent devices under product code ESD
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view all- K973665 — MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
- K944241 — MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID
- K911183 — NHS 2044P BODY AID, HEARING AID
- K911174 — NHS 2009SP HEARING AID
- K911182 — NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
Data sourced from openFDA. This site is unofficial and independent of the FDA.