The following data is part of a premarket notification filed by Micropace Pty. Ltd. with the FDA for Stimlab.
| Device ID | K072200 |
| 510k Number | K072200 |
| Device Name: | STIMLAB |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | MICROPACE PTY. LTD. 7/186-188 CANTERBURY ROAD Canterbury, Nsw, AU 2193 |
| Contact | Michael Cejnar |
| Correspondent | Michael Cejnar MICROPACE PTY. LTD. 7/186-188 CANTERBURY ROAD Canterbury, Nsw, AU 2193 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-08 |
| Decision Date | 2007-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09349714004630 | K072200 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STIMLAB 86393420 4723665 Live/Registered |
Dr. Adam Hebb 2014-09-12 |
![]() STIMLAB 85805394 not registered Dead/Abandoned |
Dr. Adam Hebb 2012-12-18 |