VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER— 510(k) K904222

Name: FDA 510(k) clearance K904222
Creator: U.S. Food and Drug Administration
Published: 1991-01-18

Substantially Equivalent

Telediagnostic Systems, Inc.

FDA 510(k) clearance K904222 for VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER, Substantially Equivalent on 1991-01-18. Applicant: Telediagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Telediagnostic Systems, Inc.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 1990-09-13
Decision date: 1991-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM1991-06-18
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Data sourced from openFDA. This site is unofficial and independent of the FDA.