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FDA 510(k)

ISTAT SOFTWARE

K-Number: K871931 · 1987-10-13

ApplicantNeuroscience, Inc.
Decision Date1987-10-13
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISTAT SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Neuroscience, Inc.. It received FDA 510(k) clearance on 1987-10-13 under 510(k) number K871931. 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 ISTAT SOFTWARE?

ISTAT SOFTWARE is a medical device that received FDA 510(k) clearance on 1987-10-13. The listed applicant is Neuroscience, Inc.. The 510(k) number is K871931.

When did ISTAT SOFTWARE receive FDA 510(k) clearance?

ISTAT SOFTWARE received FDA 510(k) clearance on 1987-10-13, under 510(k) number K871931.

Who is the listed applicant for ISTAT SOFTWARE?

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

What is the FDA product code for ISTAT SOFTWARE?

The FDA product code for ISTAT SOFTWARE 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.

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 Neuroscience, Inc. 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.

K870263NEUROMAPPER 1620K855232SOMATOSENSORY EVOKED POTENTIAL STIMULATORK850430NEUROSCIENCE MAP-10 EEG

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.K912938RHYTHMStellate SystemsK894629NICOLET BEAM II SYSTEMNicolet Instrument Corp.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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