The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Flexcomp Dsp & Procomp.
| Device ID | K903497 |
| 510k Number | K903497 |
| Device Name: | FLEXCOMP DSP & PROCOMP |
| Classification | Device, Biofeedback |
| 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 | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-03 |
| Decision Date | 1991-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540191000395 | K903497 | 000 |
| 07540191000180 | K903497 | 000 |
| 07540191000173 | K903497 | 000 |
| 07540191000166 | K903497 | 000 |
| 07540191000159 | K903497 | 000 |
| 07540191000142 | K903497 | 000 |
| 07540191000135 | K903497 | 000 |
| 07540191000128 | K903497 | 000 |
| 07540191000111 | K903497 | 000 |
| 07540191000098 | K903497 | 000 |
| 07540191000081 | K903497 | 000 |
| 07540191000074 | K903497 | 000 |
| 07540191000050 | K903497 | 000 |
| 07540191000043 | K903497 | 000 |
| 07540191000036 | K903497 | 000 |
| 07540191000197 | K903497 | 000 |
| 07540191000203 | K903497 | 000 |
| 07540191000388 | K903497 | 000 |
| 07540191000371 | K903497 | 000 |
| 07540191000364 | K903497 | 000 |
| 07540191000357 | K903497 | 000 |
| 07540191000340 | K903497 | 000 |
| 07540191000333 | K903497 | 000 |
| 07540191000326 | K903497 | 000 |
| 07540191000319 | K903497 | 000 |
| 07540191000302 | K903497 | 000 |
| 07540191000296 | K903497 | 000 |
| 07540191000258 | K903497 | 000 |
| 07540191000241 | K903497 | 000 |
| 07540191000234 | K903497 | 000 |
| 07540191000210 | K903497 | 000 |
| 07540191000029 | K903497 | 000 |