The following data is part of a premarket notification filed by Ep Technologies, Inc. with the FDA for Map Dc-coupled Isolated Preamplifier Model #1001.
| Device ID | K885252 |
| 510k Number | K885252 |
| Device Name: | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | EP TECHNOLOGIES, INC. 897 INDEPENDENCE AVE. SUITE 1- D Mountain View, CA 94043 |
| Contact | S Cooperman |
| Correspondent | S Cooperman EP TECHNOLOGIES, INC. 897 INDEPENDENCE AVE. SUITE 1- D Mountain View, CA 94043 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-14 |
| Decision Date | 1989-01-13 |