The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Statim 7000 (without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101.
| Device ID | K072466 |
| 510k Number | K072466 |
| Device Name: | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 |
| Classification | Sterilizer, Steam |
| Applicant | SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Teresa Boyce |
| Correspondent | Teresa Boyce SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-04 |
| Decision Date | 2007-12-19 |
| Summary: | summary |