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510(k) Data Aggregation
K Number
K102823Device Name
DISPOSABLE BLOOD PRESSURE CUFF
Manufacturer
Date Cleared
2011-01-07
(100 days)
Product Code
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
WUXI MEDICAL INSTRUMENT FACTORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.
Device Description
The proposed devices, Disposable blood Pressure Cuff, are claimed to be Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.
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