Home / 510(k) Clearances / K800768

510(k) K800768

VASCULAB BI-DIRECTIONAL DOPPLER, #D10 by Medasonics, Inc. — Product Code JAF

K800768 is an FDA 510(k) premarket notification submitted by Medasonics, Inc. for the device "VASCULAB BI-DIRECTIONAL DOPPLER, #D10". The FDA issued a decision of Substantially Equivalent on July 8, 1980. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Medasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
April 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances by Medasonics, Inc.

  • K991441 — CADENCE DOPPLER ULTRASOUND SYSTEM (December 28, 1999)
  • K962796 — NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM (January 21, 1997)
  • K961116 — FIRST BEAT/CARDIO BEAT/CALC (August 8, 1996)
  • K914862 — CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS (December 3, 1992)
  • K911453 — OBTRASOUND STETHOSCOPE FETAL CALC (June 20, 1991)
  • K882018 — MEDACORD PVL, PERSONAL VASCULAR LABORATORY (September 21, 1988)
  • K872292 — TRANSPECT TRANSCRANIAL DOPPLER (August 14, 1987)
  • K854734 — MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE (February 10, 1986)
  • K833588 — VASCULAR LABORATORY TREADMILL VT1 (November 14, 1983)
  • K837481 — BF24 DOPPLER MODEL P872 AND P874 (June 24, 1983)

Other clearances for product code JAF

  • K242487 — Laminar P1 (LDH-HW-001) (December 13, 2024)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • K110628 — SIMPLEABI (May 12, 2011)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)

FDA data resources