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FDA 510(k)

MODEL M402 EMG MONITOR

K-Number: K864660 · 1987-02-04

ApplicantBio-Logic Devices
Decision Date1987-02-04
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL M402 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 1987-02-04 under 510(k) number K864660. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL M402 EMG MONITOR?

MODEL M402 EMG MONITOR is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Bio-Logic Devices. The 510(k) number is K864660.

When did MODEL M402 EMG MONITOR receive FDA 510(k) clearance?

MODEL M402 EMG MONITOR received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864660.

Who is the listed applicant for MODEL M402 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 MODEL M402 EMG MONITOR?

The FDA product code for MODEL M402 EMG MONITOR is IKN.

Related Clinical Trials

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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.

K880913M424 EMG MONITORK880914T824 TEMPERATURE MONITORK880916M444 EMG MONITOR

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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