DeviceClearance

ZywieZ3 Sensor & Adhesive— 510(k) K252839

Substantially Equivalent

Zywie, Inc.

FDA 510(k) clearance K252839 for ZywieZ3 Sensor & Adhesive, Substantially Equivalent on 2026-06-18. Applicant: Zywie, Inc..

Clearance details

Applicant
Zywie, Inc.
Product code
Code MWJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Johns Creek, GA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

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.