510(k) K983915
K983915 is an FDA 510(k) premarket notification submitted by Amplifon S.P.A. for the device "AMPLAID A315 AND A319". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Amplifon S.P.A. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1999
- Date Received
- November 4, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type