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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 a medical device manufactured by Neurotronics, Inc.. It received FDA 510(k) clearance on 2017-01-19 under approval 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. It is manufactured by Neurotronics, Inc.. The 510(k) number is K161650.

When was Polysmith Sleep System, Model NTI7593 approved by the FDA?

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

What company makes Polysmith Sleep System, Model NTI7593?

Polysmith Sleep System, Model NTI7593 is manufactured by Neurotronics, Inc..

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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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023) PMID: 29082710 [How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine]. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica (2017)

Other Devices by Neurotronics, Inc.

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Related Devices (Code: OLV)

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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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