The following data is part of a premarket notification filed by Dexin Pty. Ltd. with the FDA for Sensitester.
| Device ID | K871167 |
| 510k Number | K871167 |
| Device Name: | SENSITESTER |
| Classification | Pinwheel |
| Applicant | DEXIN PTY. LTD. 221 HIGH ST. FREMANTLE, 6160 Western Australia, AU |
| Contact | Dr. S Bajada |
| Correspondent | Dr. S Bajada DEXIN PTY. LTD. 221 HIGH ST. FREMANTLE, 6160 Western Australia, AU |
| Product Code | GWY |
| CFR Regulation Number | 882.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-04-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SENSITESTER 73829137 1762633 Dead/Cancelled |
DEXIN PTY LTD 1989-10-03 |
![]() SENSITESTER 73354855 1253673 Dead/Cancelled |
Woodstream Corporation 1982-03-15 |