The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Calmtone.
| Device ID | K834519 |
| 510k Number | K834519 |
| Device Name: | CALMTONE |
| Classification | Device, Biofeedback |
| Applicant | THOUGHT TECHNOLOGY LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-01-30 |