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FDA 510(k)

M424 EMG MONITOR

K-Number: K880913 · 1988-05-11

ApplicantBio-Logic Devices
Decision Date1988-05-11
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

M424 EMG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Devices. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K880913. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M424 EMG MONITOR?

M424 EMG MONITOR is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Bio-Logic Devices. The 510(k) number is K880913.

When did M424 EMG MONITOR receive FDA 510(k) clearance?

M424 EMG MONITOR received FDA 510(k) clearance on 1988-05-11, under 510(k) number K880913.

Who is the listed applicant for M424 EMG MONITOR?

The FDA 510(k) record lists Bio-Logic Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M424 EMG MONITOR?

The FDA product code for M424 EMG MONITOR is HCC.

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Other records listing Bio-Logic Devices 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.

K880914T824 TEMPERATURE MONITORK880916M444 EMG MONITORK864660MODEL M402 EMG MONITOR

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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