Upper Arm Electronic Blood Pressure Monitor— 510(k) K202372

Substantially Equivalent

Conmo Electronic Company Limited

FDA 510(k) clearance K202372 for Upper Arm Electronic Blood Pressure Monitor, Substantially Equivalent on 2020-12-30. Applicant: Conmo Electronic Company Limited. Device class: 2.

Clearance details

Applicant
Conmo Electronic Company Limited
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
Traditional
Location
Shenzhen City, 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.