MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY— 510(k) K001013

Name: FDA 510(k) clearance K001013
Creator: U.S. Food and Drug Administration
Published: 2000-05-16

Substantially Equivalent

Airsep Corp.

FDA 510(k) clearance K001013 for MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY, Substantially Equivalent on 2000-05-16. Applicant: Airsep Corp.. Device class: 2.

Clearance details

Applicant: Airsep Corp.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2000-03-29
Decision date: 2000-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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