Sonicomp

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K833488 ↗

FDA Product Code

HEM

Device Class

Class II

Regulation

21 CFR Part 884.2225

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Fetal Heart Detector #D206

  Class II

  FDA 510(k) K800859 Active Cleared 14 May 1980

• Fetal Monitoring Sys. Model FM3R

  Class II

  FDA 510(k) K771379 Active Cleared 3 Aug 1977

• Vasoview Duplex Imaging System

  Class II

  FDA 510(k) K861237 Active Cleared 14 Jul 1986

• BV105 (&BV105R) Vascular Flow Detector W/Optional

  Class II

  FDA 510(k) K873673 Active Cleared 26 Feb 1988

• Fetal Monitoring System

  Class II

  FDA 510(k) K780487 Active Cleared 9 May 1978

• Model FM5

  Class II

  FDA 510(k) K831371 Active Cleared 30 Jun 1983

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