M4 MONITOR— 510(k) K110957

Name: FDA 510(k) clearance K110957
Creator: U.S. Food and Drug Administration
Published: 2011-05-31

Substantially Equivalent

Spectrum Medical, Llp

FDA 510(k) clearance K110957 for M4 MONITOR, Substantially Equivalent on 2011-05-31. Applicant: Spectrum Medical, Llp. Device class: 2.

Clearance details

Applicant: Spectrum Medical, Llp
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 2011-04-05
Decision date: 2011-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.