PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE— 510(k) K030939

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K030939 for PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE, Substantially Equivalent on 2003-07-15. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2003-03-25
Decision date: 2003-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Pittsburgh, PA, US

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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.