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FDA 510(k)

PULSATRON NERVE LOCATOR/STIMULATOR

K-Number: K833646 · 1984-02-10

ApplicantEdward Weck, Inc.
Decision Date1984-02-10
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PULSATRON NERVE LOCATOR/STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1984-02-10 under 510(k) number K833646. 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 PULSATRON NERVE LOCATOR/STIMULATOR?

PULSATRON NERVE LOCATOR/STIMULATOR is a medical device that received FDA 510(k) clearance on 1984-02-10. The listed applicant is Edward Weck, Inc.. The 510(k) number is K833646.

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

PULSATRON NERVE LOCATOR/STIMULATOR received FDA 510(k) clearance on 1984-02-10, under 510(k) number K833646.

Who is the listed applicant for PULSATRON NERVE LOCATOR/STIMULATOR?

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

What is the FDA product code for PULSATRON NERVE LOCATOR/STIMULATOR?

The FDA product code for PULSATRON NERVE LOCATOR/STIMULATOR is ETN.

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Other records listing Edward Weck, Inc. as applicant

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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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