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FDA 510(k)

PERSYST PRISM

K-Number: K974718 · 1998-03-09

ApplicantPersyst Development Corp.
Decision Date1998-03-09
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PERSYST PRISM 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 1998-03-09 under 510(k) number K974718. The device is classified under product code GWS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSYST PRISM?

PERSYST PRISM is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is Persyst Development Corp.. The 510(k) number is K974718.

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

PERSYST PRISM received FDA 510(k) clearance on 1998-03-09, under 510(k) number K974718.

Who is the listed applicant for PERSYST PRISM?

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 PRISM?

The FDA product code for PERSYST PRISM is GWS.

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.

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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 ELECTRODEK011397PERSYST REVEAL

Related Devices (Code: GWS)

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.

K925735EEG ANALYZERBio-Scan, Inc.K912938RHYTHMStellate SystemsK894629NICOLET BEAM II SYSTEMNicolet Instrument Corp.K871931ISTAT SOFTWARENeuroscience, Inc.K871480STD-228 SPECTRAL TREND DISPLAYGrass-Telefactor Product GroupK854662OEE_7102 EEG/TREND MONITORNihon Kohden America, Inc.

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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