PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES— 510(k) K042364

Name: FDA 510(k) clearance K042364
Creator: U.S. Food and Drug Administration
Published: 2004-09-30

Substantially Equivalent

Lamont Medical, Inc.

FDA 510(k) clearance K042364 for PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES, Substantially Equivalent on 2004-09-30. Applicant: Lamont Medical, Inc.. Device class: 2.

Clearance details

Applicant: Lamont Medical, Inc.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2004-08-31
Decision date: 2004-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

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