PMD VIEWER— 510(k) K092204

Substantially Equivalent

Spencer Technologies

FDA 510(k) clearance K092204 for PMD VIEWER, Substantially Equivalent on 2009-10-08. Applicant: Spencer Technologies.

Clearance details

Applicant
Spencer Technologies
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seattle, WA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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.