510(k) K973861
K973861 is an FDA 510(k) premarket notification submitted by Magnatone Hearing Aid Corp. for the device "FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48". The FDA issued a decision of Substantially Equivalent on November 19, 1997. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Magnatone Hearing Aid Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1997
- Date Received
- October 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Air-Conduction, Prescription
- Device Class
- Class I
- Regulation Number
- 874.3300
- Review Panel
- EN
- Submission Type
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.