Cleared Traditional

VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING

K131860 · Us Vascular, LLC · Cardiovascular

Sep 2013

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K131860 is an FDA 510(k) clearance for the VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING, a Transducer, Ultrasonic (Class II — Special Controls, product code JOP), submitted by Us Vascular, LLC (Crofton, US). The FDA issued a Cleared decision on September 27, 2013, 95 days after receiving the submission on June 24, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2880.

Submission Details

510(k) Number	K131860 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2013
Decision Date	September 27, 2013
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF