510(k) K011429
- Device
- MODEL 100 ACTIVITY MONITOR
- Applicant
- Telecom Medical, Inc.
- 510(k) number
- K011429
- Product code
- GYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-13
- Date received
- 2001-05-09
- Regulation
- 882.1950
- Classification name
- Transducer, Tremor
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- THOMAS C WEHMAN
- Address
- 10900 Lucky Oak Ct. Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3032027298
- 3011196543
- 3009134706
- 3012933969
Source Documents#
510(k) summary PDF not indicated by FDA
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