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510(k) Data Aggregation
K Number
K223693Device Name
Electric breast pump (model: M5)Manufacturer
Date Cleared
2023-03-09
(90 days)
Product Code
Regulation Number
884.5160Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
Electric breast pump (model: M5)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Electric breast pump (model: M5) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Device Description
Electric breast pump (model: M5)
AI/ML Overview
I am sorry, but this document is an FDA clearance letter for an electric breast pump. It does not contain information about acceptance criteria, device performance tables, sample sizes for test or training sets, details about ground truth establishment, or information about specific studies like MRMC or standalone algorithm performance.
Therefore, I cannot fulfill your request for that specific information based on the provided text.
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