510(k) K100661
K100661 is an FDA 510(k) premarket notification submitted by Path Medical GmbH for the device "EARPROBE". The FDA issued a decision of Substantially Equivalent on July 1, 2010. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Path Medical GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2010
- Date Received
- March 8, 2010
- 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