740 SafeSAT— 510(k) K200160

Name: FDA 510(k) clearance K200160
Creator: U.S. Food and Drug Administration
Published: 2021-02-15

Substantially Equivalent

Zoe Medical, Inc.

FDA 510(k) clearance K200160 for 740 SafeSAT, Substantially Equivalent on 2021-02-15. Applicant: Zoe Medical, Inc.. Device class: 2.

Clearance details

Applicant: Zoe Medical, Inc.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
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 ↗

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More clearances from Zoe Medical, Inc.

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K130740 — NIGHTINGALE MONITORING SYSTEM2013-07-23
K093802 — ULTRAVIEW DM3 MONITOR2010-04-09
K040012 — WELL@HOME SYSTEM2004-04-02
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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.