The following data is part of a premarket notification filed by Ultramind International Ltd. with the FDA for Ultramind Biofeedback System With De-stress Software.
| Device ID | K980373 |
| 510k Number | K980373 |
| Device Name: | ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE |
| Classification | Device, Biofeedback |
| Applicant | ULTRAMIND INTERNATIONAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman ULTRAMIND INTERNATIONAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-30 |
| Decision Date | 1998-04-29 |
| Summary: | summary |