LIFEPAK 5 MONITOR, CASSETTE, #800923-01— 510(k) K790757

Substantially Equivalent

Physio-Control Corp.

FDA 510(k) clearance K790757 for LIFEPAK 5 MONITOR, CASSETTE, #800923-01, Substantially Equivalent on 1979-06-01. Applicant: Physio-Control Corp..

Clearance details

Applicant
Physio-Control Corp.
Product code
Code DSH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DSH

product code DSH
Death
3
Injury
652
Total
655

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.