Cleared Traditional

K983229 - OLYMPIC MEDICAL LECTROMED CEREBRAL FUNC...

K983229 is an FDA 510(k) clearance for OLYMPIC MEDICAL LECTROMED CEREBRAL FUNC..., manufactured by Olympic Medical Corp.. The device is a Class 2 Neurology device with product code OMA cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K983229 · Olympic Medical Corp. · Neurology device
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Mar 1999
Decision
189d
Days
Class 2
Risk

K983229 is an FDA 510(k) clearance for the OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM. Classified as Amplitude-integrated Electroencephalograph (product code OMA), Class II - Special Controls.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on March 23, 1999 after a review of 189 days - an extended review cycle.

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 Olympic Medical Corp. devices

FDA 510(k) Submission Details - K983229

510(k) Number K983229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1998
Decision Date March 23, 1999
Days to Decision 189 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
41d slower than avg
Panel avg: 148d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMA Device Classification - Class 2, Special Controls

Product Code OMA Amplitude-integrated Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).
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 - OMA Amplitude-integrated Electroencephalograph

Devices cleared under the same product code (OMA) and FDA review panel - the closest regulatory comparables to K983229.
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K031149 · Olympic Medical Corp. · May 2003
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