Futura 67M, 68M, MEGAPOWERMP97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59, Suprema 45, 46, 47,48
FDA 510(k) K973861 · Magnatone Hearing Aid Corp.
510(k) numberK973861
Submission
- Device name
- Futura 67M, 68M, MEGAPOWERMP97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59, Suprema 45, 46, 47,48
- Applicant
- Magnatone Hearing Aid Corp.
Casselberry, FL, US - Received
- October 9, 1997
- Decision date
- November 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
Other 510(k)s with product code ESD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232999 | Lyric4 Hearing AidESD · Traditional | Sonova AG | 04/11/2024SE |
| K130790 | LYRIC2ESD · Traditional | Phonak, LLC | 06/27/2013SE |
| K081136 | Lyric Hearing AidESD · Traditional | Insound Medical, Inc. | 05/08/2008SE |
| K021867 | Insound XT Series Hearing AidESD · Traditional | Insound Medical, Inc. | 11/19/2002SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | Siemens Hearing Instruments, Inc. | 04/24/2001SE |
| K984518 | Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional | Sonic Innovations, Inc. | 03/12/1999SE |
| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
| K974242 | Argosy Programmable OnqueESD · Traditional | Argosy Electronics | 01/20/1998SE |
| K973880 | Sonix Hearing Aid Fitting and Programming SystemESD · Traditional | Sonix Technologies, Inc. | 01/12/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
More from Bernafon-Maico, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973665 | Magnatone / Sterling/ ST; Magnatone/Db; Magnatone/ Liberty/ LB; Magnatone/ Pearl/Ph…ESD · Traditional | 11/04/1997SE |
| K944241 | Magnatone Model M Prewired Faceplate Hearing AidESD · Traditional | 11/16/1994SE |
| K911183 | NHS 2044P Body Aid, Hearing AidESD · Traditional | 07/09/1991SE |
| K911182 | NNHS 2050 Series (2055W-2054PP) Hearing AidsESD · Traditional | 05/09/1991SE |
| K911174 | NHS 2009SP Hearing AidESD · Traditional | 05/09/1991SE |
| K890525 | Interton Bte Hear Aid, Supra, Suprema, MinettaESD · Traditional | 05/19/1989SE |
| K852656 | Model M Hearing AidESD · Traditional | 12/27/1985SE |
Questions and answers
When was Futura 67M, 68M, MEGAPOWERMP97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59, Suprema 45, 46, 47,48 cleared by the FDA?
Futura 67M, 68M, MEGAPOWERMP97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59, Suprema 45, 46, 47,48 (K973861) received a 510(k) decision of Substantially Equivalent on November 19, 1997, 41 days after the submission was received.
What is the product code of K973861?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.