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510(k) Data Aggregation
K Number
K972378Device Name
SANAPHON NManufacturer
Date Cleared
1997-09-24
(90 days)
Product Code
Regulation Number
870.1120Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SANAPHON N
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Sanaphon-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)
Device Description
Sanaphon-N is a sphygmomanometer
AI/ML Overview
The provided text does not contain information on acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device named SanaPhon-N, indicating its substantial equivalence to a predicate device. It defines the intended use as a sphygmomanometer for self-measurement of blood pressure.
Therefore, I cannot provide the requested information about acceptance criteria or study details from this document.
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