Somfit— 510(k) K231546

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K231546 for Somfit, Substantially Equivalent on 2023-11-30. Applicant: Compumedics Limited. Device class: 2.

Clearance details

Applicant: Compumedics Limited
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2023-05-30
Decision date: 2023-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbotsford, AU

Download summary PDF View on FDA.gov ↗

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