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.. Device class: 2.

Clearance details

Applicant
Next Millennium Software Solutions, Inc.
Product code
Code DXH
Device class
Class 2
Regulation
21 CFR 870.2920
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hialeah, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DXH

view all

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