Cleared Traditional

K973596 - SPACELABS MEDICAL 90482 BISPECTRAL INDE...

K973596 is an FDA 510(k) clearance for SPACELABS MEDICAL 90482 BISPECTRAL INDE..., manufactured by Spacelabs Medical, Inc.. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K973596 · Spacelabs Medical, Inc. · Neurology device
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Feb 1998
Decision
134d
Days
Class 2
Risk

K973596 is an FDA 510(k) clearance for the SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Redmond, US). The FDA issued a Cleared decision on February 3, 1998 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Spacelabs Medical, Inc. devices

FDA 510(k) Submission Details - K973596

510(k) Number K973596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date February 03, 1998
Days to Decision 134 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 148d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLW Device Classification - Class 2, Special Controls

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
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 - OLW Index-generating Electroencephalograph Software

All 25
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K973596.
EEG MIS MONITOR MODEL # A-2000
K011534 · Aspect Medical Systems, Inc. · Jun 2001
BIS ENGINE
K002837 · Aspect Medical Systems, Inc. · Sep 2000
A-2000 EEG MONITOR WITH BIS
K974496 · Aspect Medical Systems, Inc. · Feb 1998
A-1000 EEG MONITOR AND A-1050 EEG MONITOR
K963644 · Aspect Medical Systems, Inc. · Oct 1996