510(k) K913957
K913957 is an FDA 510(k) premarket notification submitted by Dantec Medical, Inc. for the device "DANTEC COUNTERPOINT MK2(TM)". The FDA issued a decision of Substantially Equivalent on January 30, 1992. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Dantec Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1992
- Date Received
- September 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Auditory, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1900
- Review Panel
- NE
- Submission Type