MONARK 869 ERGOMETER— 510(k) K855102

Name: FDA 510(k) clearance K855102
Creator: U.S. Food and Drug Administration
Published: 1986-05-09

Substantially Equivalent

Equilibrated Bio Systems, Inc.

FDA 510(k) clearance K855102 for MONARK 869 ERGOMETER, Substantially Equivalent on 1986-05-09. Applicant: Equilibrated Bio Systems, Inc.. Device class: 2.

Clearance details

Applicant: Equilibrated Bio Systems, Inc.
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 1985-12-23
Decision date: 1986-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.