510(k) K130165
K130165 is an FDA 510(k) premarket notification submitted by Advanced Planimetric Services, LLC for the device "PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0". The FDA issued a decision of Substantially Equivalent on August 30, 2013. The device falls under product code FXN (Tape, Camera, Surgical), a Class I device regulated under 21 CFR 878.4160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2013
- Date Received
- January 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tape, Camera, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type