NIGHTRON POLYSOMNOGRAPHY SYSTEM— 510(k) K022249

Name: FDA 510(k) clearance K022249
Creator: U.S. Food and Drug Administration
Published: 2002-12-31

Substantially Equivalent

Telediagnostic Systems, Inc.

FDA 510(k) clearance K022249 for NIGHTRON POLYSOMNOGRAPHY SYSTEM, Substantially Equivalent on 2002-12-31. Applicant: Telediagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Telediagnostic Systems, Inc.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2002-07-12
Decision date: 2002-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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