FDA.reportPublic FDA data

510(k) K131596

Device
WOUND MEASURING & MONITORING DEVICE
Applicant
WOUNDVISION, LLC
510(k) number
K131596
Product code
FXN  
Decision
Substantially Equivalent (SESE)
Decision date
2013-12-11
Date received
2013-06-03
Regulation
878.4160
Classification name
Tape, Camera, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GRETCHEN MILLER BOWKER
Address
29 E. Mccarty St. Suite 100 Indianapolis IN US 46225 46225

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FXN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130165PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0Advanced Planimetric Services, LLC2013-08-30
K070426SILHOUETTE, MODEL 1000.01Aranz Medical Limited2007-06-29
K962148VERGE VIDEOMETERVerg, Inc.1996-12-20

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases