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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K223873
FOIA Releasable 510(k) K223873
Device Name Boppli Infant Blood Pressure Monitor
Applicant
Pyrames, Inc.
21730 Stevens Creek Blvd., Suite 201a
Cupertino,  CA  95014
Applicant Contact Xina Quan
Correspondent
Pyrames, Inc.
2450 Holcombe Blvd.
Houston,  TX  77021
Correspondent Contact Isabella Schmitt
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/23/2022
Decision Date 09/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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