PROPAQ 102,104,106,102EL,104EL,&106EL— 510(k) K914838

Name: FDA 510(k) clearance K914838
Creator: U.S. Food and Drug Administration
Published: 1992-01-10

Substantially Equivalent

Protocol Systems, Inc.

FDA 510(k) clearance K914838 for PROPAQ 102,104,106,102EL,104EL,&106EL, Substantially Equivalent on 1992-01-10. Applicant: Protocol Systems, Inc.. Device class: 2.

Clearance details

Applicant: Protocol Systems, Inc.
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1991-10-25
Decision date: 1992-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.