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FDA 510(k)

CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01

K-Number: K001091 · 2000-08-10

ApplicantNext Millennium Software Solutions, Inc.
Decision Date2000-08-10
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 is the device name listed in this FDA 510(k) record. The listed applicant is Next Millennium Software Solutions, Inc.. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K001091. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01?

CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Next Millennium Software Solutions, Inc.. The 510(k) number is K001091.

When did CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 receive FDA 510(k) clearance?

CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 received FDA 510(k) clearance on 2000-08-10, under 510(k) number K001091.

Who is the listed applicant for CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01?

The FDA 510(k) record lists Next Millennium Software Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01?

The FDA product code for CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 is DXH. This falls under the Hematology category.

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Official Source

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