510(k) K010270
K010270 is an FDA 510(k) premarket notification submitted by Flexable Systems, Inc. for the device "TREMOROMETER". The FDA issued a decision of Substantially Equivalent on July 25, 2001. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2001
- Date Received
- January 29, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Tremor
- Device Class
- Class II
- Regulation Number
- 882.1950
- Review Panel
- NE
- Submission Type