WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS— 510(k) K990522

Name: FDA 510(k) clearance K990522
Creator: U.S. Food and Drug Administration
Published: 1999-05-19

Substantially Equivalent

Lamont Medical, Inc.

FDA 510(k) clearance K990522 for WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS, Substantially Equivalent on 1999-05-19. 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: 1999-02-18
Decision date: 1999-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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