The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myotrac2d/cs.
| Device ID | K925681 |
| 510k Number | K925681 |
| Device Name: | MYOTRAC2D/CS |
| Classification | Perineometer |
| Applicant | THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8 |
| Contact | Hal K Myers |
| Correspondent | Hal K Myers THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1995-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540191000494 | K925681 | 000 |