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FDA 510(k)

IF400

K-Number: K930535 · 1994-06-14

ApplicantSkylark Device Co., Ltd.
Decision Date1994-06-14
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IF400 is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device Co., Ltd.. It received FDA 510(k) clearance on 1994-06-14 under 510(k) number K930535. 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 IF400?

IF400 is a medical device that received FDA 510(k) clearance on 1994-06-14. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K930535.

When did IF400 receive FDA 510(k) clearance?

IF400 received FDA 510(k) clearance on 1994-06-14, under 510(k) number K930535.

Who is the listed applicant for IF400?

The FDA 510(k) record lists Skylark Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IF400?

The FDA product code for IF400 is LIH.

Other records listing Skylark Device Co., Ltd. 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.

K990233ST-302 INFRAREXK984506SD-100 SKYEAR THERMOMETERK981449SD-956 ULTRASOUND THERAPYK983964BATCH #6060 CONDUCTIVE GELK964437GB-1002 TENS WITH MASSAGEK974585IF-727 INTERFERENTIAL STIMULATOR

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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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