The following data is part of a premarket notification filed by Ep Technologies, Inc. with the FDA for Constant Current Stimulator Model 022101.
| Device ID | K900553 |
| 510k Number | K900553 |
| Device Name: | CONSTANT CURRENT STIMULATOR MODEL 022101 |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| 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 | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-06 |
| Decision Date | 1990-03-13 |