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FDA 510(k)

AXOSTIM NERVE STIMULATOR, MODIFICATION

K-Number: K905035 · 1991-04-19

ApplicantSinger Medical Products, Inc.
Decision Date1991-04-19
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AXOSTIM NERVE STIMULATOR, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Singer Medical Products, Inc.. It received FDA 510(k) clearance on 1991-04-19 under 510(k) number K905035. 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 AXOSTIM NERVE STIMULATOR, MODIFICATION?

AXOSTIM NERVE STIMULATOR, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is Singer Medical Products, Inc.. The 510(k) number is K905035.

When did AXOSTIM NERVE STIMULATOR, MODIFICATION receive FDA 510(k) clearance?

AXOSTIM NERVE STIMULATOR, MODIFICATION received FDA 510(k) clearance on 1991-04-19, under 510(k) number K905035.

Who is the listed applicant for AXOSTIM NERVE STIMULATOR, MODIFICATION?

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

What is the FDA product code for AXOSTIM NERVE STIMULATOR, MODIFICATION?

The FDA product code for AXOSTIM NERVE STIMULATOR, MODIFICATION is ETN.

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Other records listing Singer Medical Products, 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.

K896909MD5 AUTOMATIC AUDIOMETERK895784IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3K895783IMPEDANCE ANALYZER MODELS MD-2, MD-PK895785AUDIOMETER MODEL MD-4, MD-4PK894748IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1PK896368MODIFIED AXOSTIM

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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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