Cleared Traditional

NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101

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

About This 510(k) Submission

K971803 is an FDA 510(k) clearance for the NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Neurotronics, Inc. (Waldo, US). The FDA issued a Cleared decision on November 12, 1997, 184 days after receiving the submission on May 12, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K971803 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375