CARDIOVUE CFS-100— 510(k) K900893

Substantially Equivalent

Bv Medical Equipment Co.

FDA 510(k) clearance K900893 for CARDIOVUE CFS-100, Substantially Equivalent on 1990-04-19. Applicant: Bv Medical Equipment Co..

Clearance details

Applicant
Bv Medical Equipment Co.
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hanover, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JAA

product code JAA
Other
1
Total
1

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.