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FDA 510(k)

PERSYST REVEAL

K-Number: K011397 · 2001-08-03

ApplicantPersyst Development Corp.
Decision Date2001-08-03
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PERSYST REVEAL 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 2001-08-03 under 510(k) number K011397. 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 REVEAL?

PERSYST REVEAL is a medical device that received FDA 510(k) clearance on 2001-08-03. The listed applicant is Persyst Development Corp.. The 510(k) number is K011397.

When did PERSYST REVEAL receive FDA 510(k) clearance?

PERSYST REVEAL received FDA 510(k) clearance on 2001-08-03, under 510(k) number K011397.

Who is the listed applicant for PERSYST REVEAL?

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 REVEAL?

The FDA product code for PERSYST REVEAL is OMB.

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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.

K132306PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWAREK103103PRESSON ELECTRODEK974718PERSYST 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, LLCK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg ASK242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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