NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101— 510(k) K971803

Name: FDA 510(k) clearance K971803
Creator: U.S. Food and Drug Administration
Published: 1997-11-12

Substantially Equivalent

Neurotronics, Inc.

FDA 510(k) clearance K971803 for NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101, Substantially Equivalent on 1997-11-12. Applicant: Neurotronics, Inc.. Device class: 2.

Clearance details

Applicant: Neurotronics, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1997-05-12
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waldo, FL, US

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