VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM— 510(k) K904328

Name: FDA 510(k) clearance K904328
Creator: U.S. Food and Drug Administration
Published: 1991-06-18

Substantially Equivalent

Telediagnostic Systems, Inc.

FDA 510(k) clearance K904328 for VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM, Substantially Equivalent on 1991-06-18. Applicant: Telediagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Telediagnostic Systems, Inc.
Product code: Code GWK
Device class: Class 2
Regulation: 21 CFR 882.1845
Advisory panel: Neurology
Date received: 1990-09-20
Decision date: 1991-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-43001991-06-28

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K904222 — VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER1991-01-18
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