The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for Alphaone Biofeedback System.
| Device ID | K071661 |
| 510k Number | K071661 |
| Device Name: | ALPHAONE BIOFEEDBACK SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | TELEDIAGNOSTIC SYSTEMS, INC. 2484 OLD MIDDLEFIELD WAY SUITE 202 Mountain View, CA 94043 |
| Contact | Larry Woodward |
| Correspondent | Larry Woodward TELEDIAGNOSTIC SYSTEMS, INC. 2484 OLD MIDDLEFIELD WAY SUITE 202 Mountain View, CA 94043 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-19 |
| Decision Date | 2007-09-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B58804E0 | K071661 | 000 |
| B58802L0 | K071661 | 000 |
| B58802E0 | K071661 | 000 |