Home / 510(k) Clearances / K131860

510(k) K131860

VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING by Us Vascular, LLC — Product Code JOP

K131860 is an FDA 510(k) premarket notification submitted by Us Vascular, LLC for the device "VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING". The FDA issued a decision of Substantially Equivalent on September 27, 2013. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2013
Date Received
June 24, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type

Other clearances for product code JOP

  • K242662 — Falcon/Xpress (Falcon/Xpress) (December 18, 2024)
  • K233976 — VasoGuard (V10, V8, V6, V4, V2) (July 19, 2024)
  • K153762 — Smartdop XT6 (May 25, 2016)
  • K131623 — SMARTDOP XT (January 17, 2014)
  • K111416 — FALCON (July 15, 2011)
  • K071730 — STUDIODOP VICORDER (December 20, 2007)
  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K002766 — NICOLET VASOGUARD (November 30, 2000)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)
  • K925078 — SPECTRADOP (July 17, 1995)

FDA data resources