The following data is part of a premarket notification filed by Therapeutic Technologies, Inc. with the FDA for Neuropath 4000.
| Device ID | K854277 |
| 510k Number | K854277 |
| Device Name: | NEUROPATH 4000 |
| Classification | Device, Biofeedback |
| Applicant | THERAPEUTIC TECHNOLOGIES, INC. INT'L SQUARE #400 1825 EYE STREET NW Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney THERAPEUTIC TECHNOLOGIES, INC. INT'L SQUARE #400 1825 EYE STREET NW Washington, DC 20006 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-23 |
| Decision Date | 1986-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864267000421 | K854277 | 000 |