The following data is part of a premarket notification filed by Pro-tech Services, Inc. with the FDA for Sensor Amplifier.
| Device ID | K972515 |
| 510k Number | K972515 |
| Device Name: | SENSOR AMPLIFIER |
| Classification | Amplifier, Physiological Signal |
| Applicant | PRO-TECH SERVICES, INC. 12826 N.W. 178TH ST., SUITE A P.O. BOX 2165 Woodinville, WA 98072 |
| Contact | Anthony Zaragoza |
| Correspondent | Anthony Zaragoza PRO-TECH SERVICES, INC. 12826 N.W. 178TH ST., SUITE A P.O. BOX 2165 Woodinville, WA 98072 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-10-02 |