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510(k) K820898

VASCULAB SPECTRUM ANALYZER #SP25 by Medasonics, Inc. — Product Code DXG

K820898 is an FDA 510(k) premarket notification submitted by Medasonics, Inc. for the device "VASCULAB SPECTRUM ANALYZER #SP25". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Medasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1982
Date Received
March 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
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 DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)

FDA data resources