The following data is part of a premarket notification filed by Advanced Planimetric Services, Llc with the FDA for Pictzar Digital Planimetry Software Application 7.0.
| Device ID | K130165 |
| 510k Number | K130165 |
| Device Name: | PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 |
| Classification | Tape, Camera, Surgical |
| Applicant | ADVANCED PLANIMETRIC SERVICES, LLC 610 BOULEVARD Elmwood Park, NJ 07407 |
| Contact | Martin Wendelken |
| Correspondent | Martin Wendelken ADVANCED PLANIMETRIC SERVICES, LLC 610 BOULEVARD Elmwood Park, NJ 07407 |
| Product Code | FXN |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-23 |
| Decision Date | 2013-08-30 |
| Summary: | summary |