DeviceClearance

CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01— 510(k) K001091

Substantially Equivalent

Next Millennium Software Solutions, Inc.

FDA 510(k) clearance K001091 for CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01, Substantially Equivalent on 2000-08-10. Applicant: Next Millennium Software Solutions, Inc..

Clearance details

Applicant
Next Millennium Software Solutions, Inc.
Product code
Code DXH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hialeah, FL, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.