CEREBRAL STATE MONITOR - CSM— 510(k) K042315

Substantially Equivalent

Danmeter A/S

FDA 510(k) clearance K042315 for CEREBRAL STATE MONITOR - CSM, Substantially Equivalent on 2005-01-21. Applicant: Danmeter A/S. Device class: 2.

Clearance details

Applicant: Danmeter A/S
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2004-08-26
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Odense C, DK

Download summary PDF View on FDA.gov ↗

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More clearances from Danmeter A/S

K032954 — ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E802004-08-09
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Data sourced from openFDA. This site is unofficial and independent of the FDA.