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 |