IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM— 510(k) K971868

Name: FDA 510(k) clearance K971868
Creator: U.S. Food and Drug Administration
Published: 1997-11-13

Substantially Equivalent

Marquette Electronics, Inc.

FDA 510(k) clearance K971868 for IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM, Substantially Equivalent on 1997-11-13. Applicant: Marquette Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Marquette Electronics, Inc.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1997-05-20
Decision date: 1997-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.