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FDA 510(k)

DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX

K-Number: K910771 · 1991-12-18

ApplicantNew England Medical Instruments, Inc.
Decision Date1991-12-18
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX is the device name listed in this FDA 510(k) record. The listed applicant is New England Medical Instruments, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K910771. 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 DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX?

DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is New England Medical Instruments, Inc.. The 510(k) number is K910771.

When did DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX receive FDA 510(k) clearance?

DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX received FDA 510(k) clearance on 1991-12-18, under 510(k) number K910771.

Who is the listed applicant for DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX?

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

What is the FDA product code for DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX?

The FDA product code for DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX is OMB.

Related Clinical Trials

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Other records listing New England Medical Instruments, 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.

K955787DIGITRACE HOME VIDEO SYSTEMK910279MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER

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, LLCK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg ASK242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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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