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FDA 510(k)

INF 4160 PLUS, MODEL D-FJ31F

K-Number: K092780 · 2010-01-07

ApplicantFuji Dynamics Limited
Decision Date2010-01-07
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INF 4160 PLUS, MODEL D-FJ31F is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics Limited. It received FDA 510(k) clearance on 2010-01-07 under 510(k) number K092780. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INF 4160 PLUS, MODEL D-FJ31F?

INF 4160 PLUS, MODEL D-FJ31F is a medical device that received FDA 510(k) clearance on 2010-01-07. The listed applicant is Fuji Dynamics Limited. The 510(k) number is K092780.

When did INF 4160 PLUS, MODEL D-FJ31F receive FDA 510(k) clearance?

INF 4160 PLUS, MODEL D-FJ31F received FDA 510(k) clearance on 2010-01-07, under 510(k) number K092780.

Who is the listed applicant for INF 4160 PLUS, MODEL D-FJ31F?

The FDA 510(k) record lists Fuji Dynamics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INF 4160 PLUS, MODEL D-FJ31F?

The FDA product code for INF 4160 PLUS, MODEL D-FJ31F is LIH.

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Other records listing Fuji Dynamics Limited 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.

K063642FD EMS, MODEL # D-FJ30EK052813FD TENS 2030, MODEL DFJ24TK043407INF 4160, MODEL D-FJ27FK041164L-TENSK994265MEDISANA DIGITAL TENSK994266FDTENS 2010

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Related Devices (Code: LIH)

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.

K231575Vecttor VT-300Artaflex, Inc.K202725ETD4000Therasigma, LLCK183692Avid IF2Vision Quest Industries Inc./Dba VQ OrthocareK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORGemore Technology Co, Ltd.K121662VECTTOR VT-200Alan Neuromedical Technologies, LLCK110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments 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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