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

FDA 510(k)

PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE

K-Number: K132306 · 2013-11-21

ApplicantPersyst Development Corp.
Decision Date2013-11-21
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Persyst Development Corp.. It received FDA 510(k) clearance on 2013-11-21 under 510(k) number K132306. 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 12 EEG REVIEW AND ANALYSIS SOFTWARE?

PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-11-21. The listed applicant is Persyst Development Corp.. The 510(k) number is K132306.

When did PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE receive FDA 510(k) clearance?

PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE received FDA 510(k) clearance on 2013-11-21, under 510(k) number K132306.

Who is the listed applicant for PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE?

The FDA 510(k) record lists Persyst Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE?

The FDA product code for PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE is OMB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Persyst Development Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103103PRESSON ELECTRODEK011397PERSYST REVEALK974718PERSYST PRISM

Related Devices (Code: OMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK243743autoSCORE (V 2.0.0)Holberg Eeg ASK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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.

↑