TREMOR MONITOR— 510(k) K782036
Substantially EquivalentColumbus Instruments Intl. Corp.
FDA 510(k) clearance K782036 for TREMOR MONITOR, Substantially Equivalent on 1979-01-23. Applicant: Columbus Instruments Intl. Corp.. Device class: 2.
Clearance details
- Applicant
- Columbus Instruments Intl. Corp.
- 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
- Mchenry, IL, US
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