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FDA 510(k)

AXOSTIM

K-Number: K883807 · 1989-02-09

ApplicantSinger Medical Products, Inc.
Decision Date1989-02-09
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AXOSTIM 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 1989-02-09 under 510(k) number K883807. 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 AXOSTIM?

AXOSTIM is a medical device that received FDA 510(k) clearance on 1989-02-09. The listed applicant is Singer Medical Products, Inc.. The 510(k) number is K883807.

When did AXOSTIM receive FDA 510(k) clearance?

AXOSTIM received FDA 510(k) clearance on 1989-02-09, under 510(k) number K883807.

Who is the listed applicant for AXOSTIM?

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?

The FDA product code for AXOSTIM is BXN.

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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.

K905035AXOSTIM NERVE STIMULATOR, MODIFICATIONK896909MD5 AUTOMATIC AUDIOMETERK895783IMPEDANCE ANALYZER MODELS MD-2, MD-PK895785AUDIOMETER MODEL MD-4, MD-4PK894748IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1PK895784IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3

View all 8 devices →

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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