TREMOROMETER— 510(k) K010270
Substantially EquivalentFlexable Systems, Inc.
FDA 510(k) clearance K010270 for TREMOROMETER, Substantially Equivalent on 2001-07-25. Applicant: Flexable Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Flexable Systems, Inc.
- Product code
- Code GYD
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fountain Hills, AZ, US
Recent devices under product code GYD
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