ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM— 510(k) K130232

Substantially Equivalent

Jinxinbao Electronic Co.,Ltd

FDA 510(k) clearance K130232 for ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM, Substantially Equivalent on 2013-09-17. Applicant: Jinxinbao Electronic Co.,Ltd. Device class: 2.

Clearance details

Applicant
Jinxinbao Electronic Co.,Ltd
Product code
Code DXN
Device class
Class 2
Regulation
21 CFR 870.1130
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Wenzhou, Zhejiang, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DXN

product code DXN
Death
3
Injury
169
Malfunction
1,019
Other
2
Total
1,193

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.