C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A— 510(k) K041376

Substantially Equivalent

Analogic Corp.

FDA 510(k) clearance K041376 for C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A, Substantially Equivalent on 2004-07-20. Applicant: Analogic Corp..

Clearance details

Applicant: Analogic Corp.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2004-05-24
Decision date: 2004-07-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Peabody, MA, US

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.