Cleared Traditional

K904328 - VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM

K904328 is an FDA 510(k) clearance for VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM, manufactured by Telediagnostic Systems, Inc.. The device is a Class 2 Neurology device with product code GWK cleared through the Traditional 510(k) pathway after a 271-day FDA review.

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

FDA 510(k) Submission Details - K904328

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.

GWK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GWK Conditioner, Signal, Physiological

All 13
Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K904328.
ACTIHEART
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K841497 · Nihon Kohden America, Inc. · Jun 1984