K992749

Substantially Equivalent

ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841

Applicant
Spacelabs Medical, Inc.
Product code
MSX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redmond, WA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MSX

product code MSX
Death
59
Total
59

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.