Cleared Traditional

K904328 - VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904328 · Telediagnostic Systems, Inc. · Neurology device
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Jun 1991
Decision
271d
Days
Class 2
Risk

K904328 is an FDA 510(k) clearance for the VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM. Classified as Conditioner, Signal, Physiological (product code GWK), Class II - Special Controls.

Submitted by Telediagnostic Systems, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 18, 1991 after a review of 271 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1845 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Telediagnostic Systems, Inc. devices

Submission Details

510(k) Number K904328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1990
Decision Date June 18, 1991
Days to Decision 271 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 148d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWK Conditioner, Signal, Physiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1845
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.