DeviceClearance

Spo2 Sensor— 510(k) K202851

Substantially Equivalent

Jkh USA, LLC

FDA 510(k) clearance K202851 for Spo2 Sensor, Substantially Equivalent on 2020-11-27. Applicant: Jkh USA, LLC.

Clearance details

Applicant
Jkh USA, LLC
Product code
Code DQA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walnut, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DQA

product code DQA
Death
66
Malfunction
2,867
Other
1
Total
2,934

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.