MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921— 510(k) K071564

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K071564 for MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921, Substantially Equivalent on 2007-08-31. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2007-06-07
Decision date: 2007-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code DRG

product code DRG

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.