CARDIOSTAT 3 RECORDER— 510(k) K851044

Name: FDA 510(k) clearance K851044
Creator: U.S. Food and Drug Administration
Published: 1985-06-26

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K851044 for CARDIOSTAT 3 RECORDER, Substantially Equivalent on 1985-06-26. Applicant: Siemens Elema AB. Device class: 2.

Clearance details

Applicant: Siemens Elema AB
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1985-03-14
Decision date: 1985-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

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K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

More clearances from Siemens Elema AB

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K023354 — COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E2003-09-05
K010923 — KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E2002-01-23
K010925 — SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E2001-12-18
K002137 — CATHCOR DESKTOP2000-10-05
K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM2000-05-26

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.