Search Results
Found 1 results
510(k) Data Aggregation
K Number
K971929Device Name
AMSINO URINARY LEG BAGManufacturer
Date Cleared
1997-08-06
(71 days)
Product Code
Regulation Number
876.5250Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
AMSINO URINARY LEG BAG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Amsino Urinary Leg Bag is a device intended to collect urine.
Device Description
Not Found
AI/ML Overview
The provided text is a legally binding letter from the FDA to AMSINO International, Inc. regarding their Urinary Leg Bag, confirming its substantial equivalence to previously marketed devices. This document does not contain any information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that you've requested.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a technical report or study summary.
Ask a Question
Ask a specific question about this device
Page 1 of 1