PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521— 510(k) K071391

Substantially Equivalent

Philips Medical Systems, Inc.

FDA 510(k) clearance K071391 for PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521, Substantially Equivalent on 2007-09-07. Applicant: Philips Medical Systems, Inc..

Clearance details

Applicant: Philips Medical Systems, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2007-05-18
Decision date: 2007-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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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.