740 SafeSAT— 510(k) K200160

Substantially Equivalent

Zoe Medical, Inc.

FDA 510(k) clearance K200160 for 740 SafeSAT, Substantially Equivalent on 2021-02-15. Applicant: Zoe Medical, Inc..

Clearance details

Applicant: Zoe Medical, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2020-01-22
Decision date: 2021-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Topsfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.