510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K001091Substantially Equivalent

Cardioset (Hardware), Model Ho4; Cardioset Scl (Software), Model V3.01

Next Millennium Software Solutions, Inc., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001091 is the FDA 510(k) clearance record for CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01, a class II device, cleared for Next Millennium Software Solutions, Inc. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list one 510(k) clearance for Next Millennium Software Solutions, Inc. As of , FDA records show no recalls naming K001091.

Clearance record

Decision date
Received
(128 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Next Millennium Software Solutions, Inc. 7224 W. 29th Way, Hialeah FL
510(k) summary
Statement
Third party review
No

Clearances, product code DXH

Trailing 12 months
4 clearances under product code DXH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DXH, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260