Synchrony (20-3000)— 510(k) K242704

Substantially Equivalent

Synapse Biomedical, Inc.

FDA 510(k) clearance K242704 for Synchrony (20-3000), Substantially Equivalent on 2025-06-05. Applicant: Synapse Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Synapse Biomedical, Inc.
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2024-09-09
Decision date: 2025-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oberline, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.