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FDA 510(k)

MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING

K-Number: K860187 · 1986-03-20

ApplicantBiometer Intl. A/S
Decision Date1986-03-20
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING is the device name listed in this FDA 510(k) record. The listed applicant is Biometer Intl. A/S. It received FDA 510(k) clearance on 1986-03-20 under 510(k) number K860187. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING?

MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING is a medical device that received FDA 510(k) clearance on 1986-03-20. The listed applicant is Biometer Intl. A/S. The 510(k) number is K860187.

When did MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING receive FDA 510(k) clearance?

MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING received FDA 510(k) clearance on 1986-03-20, under 510(k) number K860187.

Who is the listed applicant for MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING?

The FDA 510(k) record lists Biometer Intl. A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING?

The FDA product code for MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING is BXN.

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Other records listing Biometer Intl. A/S 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.

K925159TOF-GUARD TRANSMISSION MONITORK914231ELPHA 2000K892396MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITORK893485ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITORK890746MYOTEST DBS NERVE STIMULATORK881196AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL

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Related Devices (Code: BXN)

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.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLCK111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.

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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