CALMTONE— 510(k) K834519

Substantially Equivalent

Thought Technology , Ltd.

FDA 510(k) clearance K834519 for CALMTONE, Substantially Equivalent on 1984-01-30. Applicant: Thought Technology , Ltd.. Device class: 2.

Clearance details

Applicant: Thought Technology , Ltd.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1983-12-21
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.