510(k) K971740
K971740 is an FDA 510(k) premarket notification submitted by Amplifon S.P.A. for the device "AMPLAID MK12". The FDA issued a decision of Substantially Equivalent on March 16, 1998. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Amplifon S.P.A. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1998
- Date Received
- May 12, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type