Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Persyst Mobile App

K-Number: K171184 · 2017-09-21

ApplicantPersyst Development Corporation
Decision Date2017-09-21
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Persyst Mobile App is a medical device manufactured by Persyst Development Corporation. It received FDA 510(k) clearance on 2017-09-21 under approval number K171184. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Persyst Mobile App?

Persyst Mobile App is a medical device that received FDA 510(k) clearance on 2017-09-21. It is manufactured by Persyst Development Corporation. The 510(k) number is K171184.

When was Persyst Mobile App approved by the FDA?

Persyst Mobile App received FDA 510(k) clearance on 2017-09-21, under approval number K171184.

What company makes Persyst Mobile App?

Persyst Mobile App is manufactured by Persyst Development Corporation.

What is the FDA product code for Persyst Mobile App?

The FDA product code for Persyst Mobile App is OMB.

Other Devices by Persyst Development Corporation

K182181Persyst 14 EEG Review and Analysis Software K222002Persyst 15 EEG Review and Analysis Software K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Related Devices (Code: OMB)

K182181Persyst 14 EEG Review and Analysis SoftwarePersyst Development Corporation K171720encevisAit Austrian Institute of Technology GmbH K180421Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K191301Ceribell Pocket EEG DeviceCeribell, Inc. K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) K211452EncevisAustrian Institute of Technology GmbH

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.

↑