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FDA 510(k)

NERVE LOCATER/STIMULATOR

K-Number: K781569 · 1978-12-07

ApplicantIntermedics, Inc.
Decision Date1978-12-07
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NERVE LOCATER/STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K781569. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NERVE LOCATER/STIMULATOR?

NERVE LOCATER/STIMULATOR is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Intermedics, Inc.. The 510(k) number is K781569.

When did NERVE LOCATER/STIMULATOR receive FDA 510(k) clearance?

NERVE LOCATER/STIMULATOR received FDA 510(k) clearance on 1978-12-07, under 510(k) number K781569.

Who is the listed applicant for NERVE LOCATER/STIMULATOR?

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

What is the FDA product code for NERVE LOCATER/STIMULATOR?

The FDA product code for NERVE LOCATER/STIMULATOR is ETN.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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Related Devices (Code: ETN)

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.

K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)Medtronic Xomed, Inc.K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLCK232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., 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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