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FDA 510(k)

INF 4160, MODEL D-FJ27F

K-Number: K043407 · 2005-02-11

ApplicantFuji Dynamics Limited
Decision Date2005-02-11
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INF 4160, MODEL D-FJ27F 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 2005-02-11 under 510(k) number K043407. 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, MODEL D-FJ27F?

INF 4160, MODEL D-FJ27F is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Fuji Dynamics Limited. The 510(k) number is K043407.

When did INF 4160, MODEL D-FJ27F receive FDA 510(k) clearance?

INF 4160, MODEL D-FJ27F received FDA 510(k) clearance on 2005-02-11, under 510(k) number K043407.

Who is the listed applicant for INF 4160, MODEL D-FJ27F?

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, MODEL D-FJ27F?

The FDA product code for INF 4160, MODEL D-FJ27F 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.

K092780INF 4160 PLUS, MODEL D-FJ31FK063642FD EMS, MODEL # D-FJ30EK052813FD TENS 2030, MODEL DFJ24TK041164L-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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