510(k) K782036
K782036 is an FDA 510(k) premarket notification submitted by Columbus Instruments Intl. Corp. for the device "TREMOR MONITOR". The FDA issued a decision of Substantially Equivalent on January 23, 1979. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950. Columbus Instruments Intl. Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1979
- Date Received
- December 5, 1978
- 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