ERG 555 COUCH ERGOMETER— 510(k) K854493

Name: FDA 510(k) clearance K854493
Creator: U.S. Food and Drug Administration
Published: 1986-06-16

Substantially Equivalent

Robert Bosch Corp.

FDA 510(k) clearance K854493 for ERG 555 COUCH ERGOMETER, Substantially Equivalent on 1986-06-16. Applicant: Robert Bosch Corp.. Device class: 2.

Clearance details

Applicant: Robert Bosch Corp.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1985-11-12
Decision date: 1986-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. James, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Robert Bosch Corp.

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K854491 — ERG 550 ERGOMETER BICYCLE1986-06-16
K854492 — ERG 551 ERGOMETER, BICYCLE1986-06-16
K853154 — HV-41986-03-28
K853541 — SP 41986-03-28
K853271 — HEARING AID ANALYSIS SYSTEM1986-01-16

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.