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FDA 510(k)

NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101

K-Number: K971803 · 1997-11-12

ApplicantNeurotronics, Inc.
Decision Date1997-11-12
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K971803. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101?

NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Neurotronics, Inc.. The 510(k) number is K971803.

When did NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 receive FDA 510(k) clearance?

NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 received FDA 510(k) clearance on 1997-11-12, under 510(k) number K971803.

Who is the listed applicant for NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101?

The FDA 510(k) record lists Neurotronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101?

The FDA product code for NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 is MNR.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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