Cleared Special

K983913 - MODIFICATION TO BIO-LOGIC SLEEPSCAN

K983913 is an FDA 510(k) clearance for MODIFICATION TO BIO-LOGIC SLEEPSCAN, manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code OLV cleared through the Special 510(k) pathway after a 21-day FDA review.

K983913 · Bio-Logic Systems Corp. · Neurology device
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Nov 1998
Decision
21d
Days
Class 2
Risk

K983913 is an FDA 510(k) clearance for the MODIFICATION TO BIO-LOGIC SLEEPSCAN. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K983913

510(k) Number K983913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1998
Decision Date November 25, 1998
Days to Decision 21 days
Submission Type Special
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
127d faster than avg
Panel avg: 148d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

OLV Device Classification - Class 2, Special Controls

Product Code OLV Standard Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
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 - OLV Standard Polysomnograph With Electroencephalograph

All 27
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K983913.
NEUROFAX, MODEL EEG-1100A
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AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · Nihon Kohden America, Inc. · Dec 1998
EMBLA
K971813 · Ferguson Medical · Jan 1998
ALICE
K922106 · Healthdyne, Inc. · Jul 1994
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
K860458 · Oxford Medilog, Inc. · Aug 1986