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FDA 510(k)

VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING

K-Number: K131860 · 2013-09-27

ApplicantUs Vascular, LLC
Decision Date2013-09-27
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING is the device name listed in this FDA 510(k) record. The listed applicant is Us Vascular, LLC. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K131860. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING?

VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Us Vascular, LLC. The 510(k) number is K131860.

When did VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING receive FDA 510(k) clearance?

VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING received FDA 510(k) clearance on 2013-09-27, under 510(k) number K131860.

Who is the listed applicant for VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING?

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

What is the FDA product code for VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING?

The FDA product code for VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING is JOP.

Related Clinical Trials

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Related Devices (Code: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, LimitedK010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1Echocath, 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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