HEART RATE/RESPIRATION SIMULATOR 8310— 510(k) K841363

Name: FDA 510(k) clearance K841363
Creator: U.S. Food and Drug Administration
Published: 1984-10-02

Substantially Equivalent

Aequitron Medical, Inc.

FDA 510(k) clearance K841363 for HEART RATE/RESPIRATION SIMULATOR 8310, Substantially Equivalent on 1984-10-02. Applicant: Aequitron Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aequitron Medical, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1984-04-02
Decision date: 1984-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.