Home / 510(k) Clearances / K130165

510(k) K130165

PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 by Advanced Planimetric Services, LLC — Product Code FXN

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

Other clearances for product code FXN

  • K131596 — WOUND MEASURING & MONITORING DEVICE (December 11, 2013)
  • K070426 — SILHOUETTE, MODEL 1000.01 (June 29, 2007)
  • K962148 — VERGE VIDEOMETER (December 20, 1996)