Cleared Special

K052066 - CEEGRAPH/SLEEPSCAN NETLINK TRAVELER

K052066 is an FDA 510(k) clearance for CEEGRAPH/SLEEPSCAN NETLINK TRAVELER, 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 25-day FDA review.

K052066 · Bio-Logic Systems Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
25d
Days
Class 2
Risk

K052066 is an FDA 510(k) clearance for the CEEGRAPH/SLEEPSCAN NETLINK TRAVELER. 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 August 26, 2005 after a review of 25 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.

FDA 510(k) Submission Details - K052066

510(k) Number K052066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2005
Decision Date August 26, 2005
Days to Decision 25 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
124d faster than avg
Panel avg: 149d · This submission: 25d
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

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K052066 · CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
Download PDF FDA Summary Bio-Logic Systems Cor…