K240729

Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)

510(k) number
K240729
Device name
Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)
Applicant
Shenzhen Pango Medical Electronics Co., Ltd. CN
Product code
DXN — System, Measurement, Blood-Pressure, Non-Invasive
Decision date
2024-06-14
Date received
2024-03-18
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K240729.pdf

Official FDA record: K240729
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.