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Polysmith Sleep System, Model NTI7593

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161650
510(k) Type
Traditional
Applicant
Neurotronics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/19/2017
Days to Decision
218 days
Submission Type
Summary

Polysmith Sleep System, Model NTI7593

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161650
510(k) Type
Traditional
Applicant
Neurotronics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/19/2017
Days to Decision
218 days
Submission Type
Summary