The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Thought Technology Vaginal & Rectal Electrode.
| Device ID | K932149 |
| 510k Number | K932149 |
| Device Name: | THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE |
| 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 | 1993-05-04 |
| Decision Date | 1995-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540191000432 | K932149 | 000 |
| 07540191000425 | K932149 | 000 |