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FDA 510(k)

MODAC-XXXX INTENSIVE MONITORING OF EEG

K-Number: K860128 · 1986-03-27

ApplicantGrass-Telefactor Product Group
Decision Date1986-03-27
Product CodeGYE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODAC-XXXX INTENSIVE MONITORING OF EEG is the device name listed in this FDA 510(k) record. The listed applicant is Grass-Telefactor Product Group. It received FDA 510(k) clearance on 1986-03-27 under 510(k) number K860128. The device is classified under product code GYE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODAC-XXXX INTENSIVE MONITORING OF EEG?

MODAC-XXXX INTENSIVE MONITORING OF EEG is a medical device that received FDA 510(k) clearance on 1986-03-27. The listed applicant is Grass-Telefactor Product Group. The 510(k) number is K860128.

When did MODAC-XXXX INTENSIVE MONITORING OF EEG receive FDA 510(k) clearance?

MODAC-XXXX INTENSIVE MONITORING OF EEG received FDA 510(k) clearance on 1986-03-27, under 510(k) number K860128.

Who is the listed applicant for MODAC-XXXX INTENSIVE MONITORING OF EEG?

The FDA 510(k) record lists Grass-Telefactor Product Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODAC-XXXX INTENSIVE MONITORING OF EEG?

The FDA product code for MODAC-XXXX INTENSIVE MONITORING OF EEG is GYE.

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 Grass-Telefactor Product Group 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.

K992291H20- TETHERED OPTIONK974583DEEGLITEK974587H2OK972202DEEG-LITEK925838TELEFACTOR D/EEG-32K884937BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING

View all 12 devices →

Related Devices (Code: GYE)

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.

K963195WIRELESS EEG RECORDING SYSTEM MODEL W32Cme Telemetrix, Inc.K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERTelediagnostic Systems, Inc.K895895MODEL 219 TELEMETRY SYSTEMMennen Medical, Inc.K891405BMS-2000 MOBILE EEG SYSTEMBuckman Co., Inc.K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERTelediagnostic Systems, Inc.K883947ISO-100 ISOLATION AMPLIFIERTelediagnostic Systems, 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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