510(k) K082035
K082035 is an FDA 510(k) premarket notification submitted by Maico Diagnostics for the device "MAICO MB 11 WITH BERAPHONE PROBE". The FDA issued a decision of Substantially Equivalent on January 29, 2009. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Maico Diagnostics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2009
- Date Received
- July 17, 2008
- 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