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510(k) Data Aggregation
K Number
K014023Device Name
BABY TEETHER, MODEL 20104Manufacturer
Date Cleared
2002-08-02
(239 days)
Product Code
Regulation Number
872.5550Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
BABY TEETHER, MODEL 20104
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
FOR BABY TO CHEW AND PLAY WITH.
Device Description
BABY TEETHER
AI/ML Overview
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a "Baby Teether" device. It confirms the substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed.
The document discusses regulatory compliance, labeling, and good manufacturing practices, but it does not detail any specific performance acceptance criteria or a study that evaluated the device's performance against such criteria.
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