510(k) K944241
K944241 is an FDA 510(k) premarket notification submitted by Magnatone Hearing Aid Corp. for the device "MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID". The FDA issued a decision of Substantially Equivalent on Nov 16, 1994. 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 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 1994
- Date Received
- Aug 31, 1994
- 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
- 510(k) Exempt
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.