The following data is part of a premarket notification filed by Columbus Instruments Intl. Corp. with the FDA for Tremor Monitor.
| Device ID | K782036 |
| 510k Number | K782036 |
| Device Name: | TREMOR MONITOR |
| Classification | Transducer, Tremor |
| Applicant | COLUMBUS INSTRUMENTS INTL. CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYD |
| CFR Regulation Number | 882.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-05 |
| Decision Date | 1979-01-23 |