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FDA 510(k)

WOUND MEASURING & MONITORING DEVICE

K-Number: K131596 · 2013-12-11

ApplicantWoundvision, LLC
Decision Date2013-12-11
Product CodeFXN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WOUND MEASURING & MONITORING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Woundvision, LLC. It received FDA 510(k) clearance on 2013-12-11 under 510(k) number K131596. The device is classified under product code FXN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOUND MEASURING & MONITORING DEVICE?

WOUND MEASURING & MONITORING DEVICE is a medical device that received FDA 510(k) clearance on 2013-12-11. The listed applicant is Woundvision, LLC. The 510(k) number is K131596.

When did WOUND MEASURING & MONITORING DEVICE receive FDA 510(k) clearance?

WOUND MEASURING & MONITORING DEVICE received FDA 510(k) clearance on 2013-12-11, under 510(k) number K131596.

Who is the listed applicant for WOUND MEASURING & MONITORING DEVICE?

The FDA 510(k) record lists Woundvision, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOUND MEASURING & MONITORING DEVICE?

The FDA product code for WOUND MEASURING & MONITORING DEVICE is FXN.

Related Clinical Trials

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Related Devices (Code: FXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130165PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0Advanced Planimetric Services, LLCK070426SILHOUETTE, MODEL 1000.01Aranz Medical LimitedK962148VERGE VIDEOMETERVerg, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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