The following data is part of a premarket notification filed by Professional Health Technologies, Inc. with the FDA for Phd-36 Physiological Signal Amplifier.
| Device ID | K860289 |
| 510k Number | K860289 |
| Device Name: | PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER |
| Classification | Amplifier, Physiological Signal |
| Applicant | PROFESSIONAL HEALTH TECHNOLOGIES, INC. 915 CAMINO DEL MAR, STE 100 Del Mar, CA 92014 |
| Contact | Theodore Benson |
| Correspondent | Theodore Benson PROFESSIONAL HEALTH TECHNOLOGIES, INC. 915 CAMINO DEL MAR, STE 100 Del Mar, CA 92014 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-08-25 |