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 |