The following data is part of a premarket notification filed by Mindmedia Labs, Inc. with the FDA for Bio Trol.
| Device ID | K972723 |
| 510k Number | K972723 |
| Device Name: | BIO TROL |
| Classification | Device, Biofeedback |
| Applicant | MINDMEDIA LABS, INC. 1036 WILLA LAKE CIRCLE Oveida, FL 32765 |
| Contact | Tom Allen |
| Correspondent | Tom Allen MINDMEDIA LABS, INC. 1036 WILLA LAKE CIRCLE Oveida, FL 32765 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1997-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540191000449 | K972723 | 000 |
| 07540191000562 | K972723 | 000 |