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K Number
K970488
Device Name
HYDROCHECK MICRO FILTER
Manufacturer
WHITE RIVER CONCEPTS
Date Cleared
1997-11-04

(267 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The White River Hydrocheck Micro Filter is designed to remove particulate matter and prevent the passage of breast milk in vacuum lines and vacuum controlled breast pumps.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Hydrocheck Micro Filter for Breast Pumps" and its "Indications for Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

Therefore, I cannot fulfill your request using the provided text.

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).