DeviceClearance

Polysmith Sleep System, Model NTI7593— 510(k) K161650

Substantially Equivalent

Neurotronics, Inc.

FDA 510(k) clearance K161650 for Polysmith Sleep System, Model NTI7593, Substantially Equivalent on 2017-01-19. Applicant: Neurotronics, Inc..

Clearance details

Applicant
Neurotronics, Inc.
Product code
Code OLV
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gainesville, FL, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.