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FDA 510(k)

RHYTHM

K-Number: K912938 · 1991-07-30

ApplicantStellate Systems
Decision Date1991-07-30
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RHYTHM is the device name listed in this FDA 510(k) record. The listed applicant is Stellate Systems. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K912938. 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 RHYTHM?

RHYTHM is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Stellate Systems. The 510(k) number is K912938.

When did RHYTHM receive FDA 510(k) clearance?

RHYTHM received FDA 510(k) clearance on 1991-07-30, under 510(k) number K912938.

Who is the listed applicant for RHYTHM?

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

What is the FDA product code for RHYTHM?

The FDA product code for RHYTHM is GWS.

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Related PubMed Literature

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.

PMID: 30115367The multiple arrhythmia dataset evaluation database (M.A.D.A.E.).Journal of electrocardiology ()PMID: 41807277QT Myopia and Cardiac Safety: Expanding the Aperture of Arrhythmia Assessment in Early Phase Drug Development.Clinical and translational science ()

Other records listing Stellate Systems 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.

K083577HARMONIE SYSTEMK013450NOTTA AMBULATORY RECORDERK010728HARMONE-SCHWARZER EEG SYSTEMK982351LUNAK955577ECLIPSE VERSION 3.0K960273HARMONIE SENSA

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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.

K974718PERSYST PRISMPersyst Development Corp.K925735EEG ANALYZERBio-Scan, Inc.K894629NICOLET 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

View on FDA Database →

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

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