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510(k) Data Aggregation
K Number
K223873Device Name
Boppli Infant Blood Pressure Monitor
Manufacturer
Date Cleared
2023-09-29
(280 days)
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
PyrAmes Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Boppli Infant Blood Pressure Monitor is indicated for use by medically trained personnel in clinical settings, such as the NICU, PICU, CVICU, and emergency or operating room, to continuously monitor diastolic, systolic, and mean arterial blood pressures of neonates and infants, under 5 kilograms in weight, who have a palpable pulse.
Device Description
The Boppli Infant Blood Pressure Monitor, or Boppli Device, is a non-invasive blood pressure monitor that utilizes a reusable mobile tablet electronic interface (Boppli Bedside) with a single-use non-invasive sensor band (Boppli Band) that is placed on the arm or leg of an infant over a palpable pulse point, such as the radial or dorsalis pedis artery, respectively. The device uses proprietary algorithms to derive the arterial pressure and display systolic (SBP) and diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse rate (PR), and a continuous pressure waveform. The device allows healthcare providers to monitor a neonate's blood pressure in clinical settings.
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