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FDA 510(k)

HEMOSTAT/STIMULATOR PROBE

K-Number: K895676 · 1989-12-08

ApplicantRln Systems, Inc.
Decision Date1989-12-08
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEMOSTAT/STIMULATOR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Rln Systems, Inc.. It received FDA 510(k) clearance on 1989-12-08 under 510(k) number K895676. 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 HEMOSTAT/STIMULATOR PROBE?

HEMOSTAT/STIMULATOR PROBE is a medical device that received FDA 510(k) clearance on 1989-12-08. The listed applicant is Rln Systems, Inc.. The 510(k) number is K895676.

When did HEMOSTAT/STIMULATOR PROBE receive FDA 510(k) clearance?

HEMOSTAT/STIMULATOR PROBE received FDA 510(k) clearance on 1989-12-08, under 510(k) number K895676.

Who is the listed applicant for HEMOSTAT/STIMULATOR PROBE?

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

What is the FDA product code for HEMOSTAT/STIMULATOR PROBE?

The FDA product code for HEMOSTAT/STIMULATOR PROBE is ETN.

Related Clinical Trials

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.

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Other records listing Rln Systems, 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.

K003745LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ETK954601NERVE LOCATOR/MONITOR SYSTEM MODIFICATIONK925008RLN NERVE LOCATOR/MONITOR; MODEL AK912508NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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