510(k) clearances

Hemotag Analysis Software (HAS)

Aventusoft, LLC · Cardiovascular

K252736Substantially EquivalentTraditionalDQD
Open FDA's page for this record
Third party flag
N
City
Boca Raton
Advisory committee description
Cardiovascular
Address 1
3651 Fau Blvd.
Address 2
Suite 300
Statement or summary
Summary
Product code
DQD
Zip code
33431
Applicant
Aventusoft, LLC
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
Hemotag Analysis Software (HAS)
Advisory committee
CV
Contact
Gary Becker
K number
K252736
State
FL
Date received
2025-08-28
Review advisory committee
CV
Postal code
33431
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stethoscope, Electronic
Medical specialty description
Cardiovascular
Regulation number
870.1875
Device class
2
Registration number
8010482, 3007615597, 3013689228, 3010399798, 3010262192, 3015907115, 1000548922, 3014579161, 3000130829, 3012421607, 3020741819, 3013757696, 3010097171, 3011359729, 3046006026, 3008820594, 3030626857, 3017394506, 3016864576, 3002736372, 3042167640, 3003174284, 3010106598, 3009756153, 1926681, 3043226252, 3011167030, 3012494290, 3004009431, 3012678246, 3011721071, 3013557562, 3011651230, 3015134086, 3017026146, 3016442138, 3004582233, 3018783553, 3008293988, 3009715978 +11 more
FEI number
3007615597, 3013689228, 3010399798, 3010262192, 3015907115, 1000548922, 3014579161, 3000130829, 3012421607, 3020741819, 3013757696, 3010097171, 3011359729, 3046006026, 3008820594, 3030626857, 1000292048, 3017394506, 3016864576, 3042167640, 3004631140, 3003174284, 3010106598, 3009756153, 1926681, 3043226252, 3011167030, 3012494290, 3004009431, 3012678246, 3011721071, 3013557562, 3011651230, 3015134086, 3017026146, 3016442138, 3004582233, 3018783553, 3008293988, 3009715978 +11 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.