The following data is part of a premarket notification filed by Micropace Pty. Ltd. with the FDA for Eps320 Cardiac Stimulator.
| Device ID | K011826 |
| 510k Number | K011826 |
| Device Name: | EPS320 CARDIAC STIMULATOR |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | MICROPACE PTY. LTD. 571 CANTERBURY RD. Campsie, N.s.w., AU 2194 |
| Contact | Michael Cejnar |
| Correspondent | Michael Cejnar MICROPACE PTY. LTD. 571 CANTERBURY RD. Campsie, N.s.w., AU 2194 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-11 |
| Decision Date | 2002-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09349714004623 | K011826 | 000 |