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FDA 510(k)

PERSYST SPIKE DETECTOR

K-Number: K950117 · 1995-04-05

ApplicantPersyst Consulting Services, Inc.
Decision Date1995-04-05
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PERSYST SPIKE DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Persyst Consulting Services, Inc.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K950117. 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 SPIKE DETECTOR?

PERSYST SPIKE DETECTOR is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Persyst Consulting Services, Inc.. The 510(k) number is K950117.

When did PERSYST SPIKE DETECTOR receive FDA 510(k) clearance?

PERSYST SPIKE DETECTOR received FDA 510(k) clearance on 1995-04-05, under 510(k) number K950117.

Who is the listed applicant for PERSYST SPIKE DETECTOR?

The FDA 510(k) record lists Persyst Consulting Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERSYST SPIKE DETECTOR?

The FDA product code for PERSYST SPIKE DETECTOR is OMB.

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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

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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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