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510(k) Data Aggregation
K Number
K233580Device Name
A Breathing System (ABS)
Manufacturer
DeepWell DTx Inc.
Date Cleared
2024-08-01
(268 days)
Product Code
HCC
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
DeepWell DTx Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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