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K Number
K253964

Validate with FDA (Live)

Device Name
Disposable Neonatal NIBP Cuff (U1681S-C51N)
Manufacturer
Unimed Medical Supplies, Inc.
Date Cleared
2026-01-09

(29 days)

Product Code
DXQ
Regulation Number
870.1120
Type
Special
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).