The following data is part of a premarket notification filed by Flexable Systems, Inc. with the FDA for Tremorometer.
| Device ID | K010270 |
| 510k Number | K010270 |
| Device Name: | TREMOROMETER |
| Classification | Transducer, Tremor |
| Applicant | FLEXABLE SYSTEMS, INC. 16410 E. TOMSTONE AVE. Fountain Hills, AZ 85268 -6545 |
| Contact | Robert M Tripp |
| Correspondent | Robert M Tripp FLEXABLE SYSTEMS, INC. 16410 E. TOMSTONE AVE. Fountain Hills, AZ 85268 -6545 |
| Product Code | GYD |
| CFR Regulation Number | 882.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-07-25 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TREMOROMETER 75677248 2435811 Dead/Cancelled |
FlexAble Systems, Inc. 1999-04-09 |