Cleared Traditional

K971803 - NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101

K971803 is an FDA 510(k) clearance for NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101, manufactured by Neurotronics, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K971803 · Neurotronics, Inc. · Anesthesiology device
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Nov 1997
Decision
184d
Days
Class 2
Risk

K971803 is an FDA 510(k) clearance for the NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Neurotronics, Inc. (Waldo, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 184 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurotronics, Inc. devices

FDA 510(k) Submission Details - K971803

510(k) Number K971803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date November 12, 1997
Days to Decision 184 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 140d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 65
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K971803.
SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999
SMARTRECORDER, MODEL 2500
K990199 · Respironics, Inc. · Apr 1999
STARDUST
K973920 · Respironics, Inc. · May 1998
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K971501 · Bio-Logic Systems Corp. · Oct 1997
SLEEPWIZARD
K964494 · Nellcor Puritan Bennett, Inc. · Feb 1997
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
K962103 · Bio-Logic Systems Corp. · Aug 1996