TREMOROMETER
FDA 510(k) clearance K010270 · decided 2001-07-25
Clearance details
- K-number
- K010270
- Device name
- TREMOROMETER
- Applicant
- Flexable Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-29
- Decision date
- 2001-07-25
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- GYD
- Device class
- 2
- Regulation number
- 882.1950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fountain Hills, AZ, US
- Third-party review
- No
- Expedited review
- No
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| Personal Kinetigraph (PKG) System (K161717) | Gkc Manufacturing Pty, Ltd. | 2016-09-20 |
| PERSONAL KINETIGRAPH (PKG) SYSTEM (K140086) | Gkc Manufacturing Pty, Ltd. | 2014-08-22 |
| KINESIA (K063872) | Cleveland Medical Devices, Inc. | 2007-04-06 |
| MODEL 100 ACTIVITY MONITOR (K011429) | Telecom Medical, Inc. | 2001-07-13 |
| MM-1 MOVEMENT MONITOR (K971318) | Axon Instruments, Inc. | 1997-07-28 |
| TREMOR MONITOR (K782036) | Columbus Instruments Intl. Corp. | 1979-01-23 |
Recalls involving this device
No recalls on record reference this clearance.