Cleared Traditional

K983072 - AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201

K983072 is an FDA 510(k) clearance for AMBULATORY EEG/SLEEP RECORDER AND ACCES..., manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983072 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
90d
Days
Class 2
Risk

K983072 is an FDA 510(k) clearance for the AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on December 1, 1998 after a review of 90 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K983072

510(k) Number K983072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1998
Decision Date December 01, 1998
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 59
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K983072.
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