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510(k) K833902

VASOSCAN by Sonicaid, Inc. — Product Code JOP

K833902 is an FDA 510(k) premarket notification submitted by Sonicaid, Inc. for the device "VASOSCAN". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Sonicaid, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
November 14, 1983
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 by Sonicaid, Inc.

  • K873673 — BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL (February 26, 1988)
  • K872074 — 5 MHZ TRANSDUCER (August 25, 1987)
  • K863803 — VASOPULSE(TM)/MODEL 5000 (May 6, 1987)
  • K862720 — VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES (November 17, 1986)
  • K861237 — VASOVIEW DUPLEX IMAGING SYSTEM (July 14, 1986)
  • K851102 — VASOSCREEN IMPEDANCE PLETHYSMOGRAPH (May 16, 1985)
  • K832374 — PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH (December 1, 1983)
  • K833488 — SONICOMP (November 28, 1983)
  • K833227 — SONICAID MODEL D206E AIR EMBOLI-DETECT (October 27, 1983)
  • K831371 — MODEL FM5 (June 30, 1983)

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)
  • K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (September 27, 2013)
  • 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)

FDA data resources