The following data is part of a premarket notification filed by Notal Vision Ltd. with the FDA for Foresee Home.
| Device ID | K091579 |
| 510k Number | K091579 |
| Device Name: | FORESEE HOME |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | NOTAL VISION LTD. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy Gordon |
| Correspondent | Judy Gordon NOTAL VISION LTD. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017803005 | K091579 | 000 |