510(k) K091579
K091579 is an FDA 510(k) premarket notification submitted by Notal Vision , Ltd. for the device "FORESEE HOME". The FDA issued a decision of Substantially Equivalent on December 23, 2009. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Notal Vision , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2009
- Date Received
- June 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perimeter, Automatic, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1605
- Review Panel
- OP
- Submission Type