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FDA 510(k)

MYOTEST DBS NERVE STIMULATOR

K-Number: K890746 · 1989-07-14

ApplicantBiometer Intl. A/S
Decision Date1989-07-14
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MYOTEST DBS NERVE STIMULATOR 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 1989-07-14 under 510(k) number K890746. 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 MYOTEST DBS NERVE STIMULATOR?

MYOTEST DBS NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Biometer Intl. A/S. The 510(k) number is K890746.

When did MYOTEST DBS NERVE STIMULATOR receive FDA 510(k) clearance?

MYOTEST DBS NERVE STIMULATOR received FDA 510(k) clearance on 1989-07-14, under 510(k) number K890746.

Who is the listed applicant for MYOTEST DBS NERVE STIMULATOR?

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 MYOTEST DBS NERVE STIMULATOR?

The FDA product code for MYOTEST DBS NERVE STIMULATOR is BXN.

Related Clinical Trials

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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 MONITORK881196AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNALK870619ACCELOGRAPH

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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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