ACUSON PHYSIOLOGICAL CONTROL MODULE— 510(k) K871239

Name: FDA 510(k) clearance K871239
Creator: U.S. Food and Drug Administration
Published: 1987-06-05

Substantially Equivalent

Acuson Computed Sonography

FDA 510(k) clearance K871239 for ACUSON PHYSIOLOGICAL CONTROL MODULE, Substantially Equivalent on 1987-06-05. Applicant: Acuson Computed Sonography. Device class: 2.

Clearance details

Applicant: Acuson Computed Sonography
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1987-03-27
Decision date: 1987-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K893863 — ACUSON L538 TRANSDUCER1990-05-23
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K874861 — ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.1988-05-11
K874363 — ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.1988-05-02
K874922 — ACUSON TRANSPERINEAL NEEDLE GUIDE1988-02-19

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.