PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES— 510(k) K020708

Substantially Equivalent

Philips Medical Systems, Inc.

FDA 510(k) clearance K020708 for PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES, Substantially Equivalent on 2002-04-25. Applicant: Philips Medical Systems, Inc..

Clearance details

Applicant
Philips Medical Systems, Inc.
Product code
Code DPS
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Andover, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DPS

product code DPS
Death
7
Total
7

Source: openFDA MAUDE database, through . 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.