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FDA 510(k)

Polysmith Sleep System, Model NTI7593

K-Number: K161650 · 2017-01-19

ApplicantNeurotronics, Inc.
Decision Date2017-01-19
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Polysmith Sleep System, Model NTI7593 is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161650. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polysmith Sleep System, Model NTI7593?

Polysmith Sleep System, Model NTI7593 is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Neurotronics, Inc.. The 510(k) number is K161650.

When did Polysmith Sleep System, Model NTI7593 receive FDA 510(k) clearance?

Polysmith Sleep System, Model NTI7593 received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161650.

Who is the listed applicant for Polysmith Sleep System, Model NTI7593?

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 Polysmith Sleep System, Model NTI7593?

The FDA product code for Polysmith Sleep System, Model NTI7593 is OLV.

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Official Source

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

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