UNIVERSAL MEDDARS SYSTEM— 510(k) K830791

Substantially Equivalent

Electronics For Medicine, Inc.

FDA 510(k) clearance K830791 for UNIVERSAL MEDDARS SYSTEM, Substantially Equivalent on 1983-06-22. Applicant: Electronics For Medicine, Inc..

Clearance details

Applicant
Electronics For Medicine, Inc.
Product code
Code DPS
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 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.