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FDA 510(k)

SD-730 IF-SDS, PERFECT PULSE IF-SDS

K-Number: K992652 · 2000-02-03

ApplicantSkylark Device & Systems Co., Ltd.
Decision Date2000-02-03
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SD-730 IF-SDS, PERFECT PULSE IF-SDS is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device & Systems Co., Ltd.. It received FDA 510(k) clearance on 2000-02-03 under 510(k) number K992652. 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 SD-730 IF-SDS, PERFECT PULSE IF-SDS?

SD-730 IF-SDS, PERFECT PULSE IF-SDS is a medical device that received FDA 510(k) clearance on 2000-02-03. The listed applicant is Skylark Device & Systems Co., Ltd.. The 510(k) number is K992652.

When did SD-730 IF-SDS, PERFECT PULSE IF-SDS receive FDA 510(k) clearance?

SD-730 IF-SDS, PERFECT PULSE IF-SDS received FDA 510(k) clearance on 2000-02-03, under 510(k) number K992652.

Who is the listed applicant for SD-730 IF-SDS, PERFECT PULSE IF-SDS?

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

What is the FDA product code for SD-730 IF-SDS, PERFECT PULSE IF-SDS?

The FDA product code for SD-730 IF-SDS, PERFECT PULSE IF-SDS is LIH.

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Other records listing Skylark Device & Systems 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.

K053007SKYLARK URO PROBEK050174BIO-STIM KITK043306SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IRK034005SDS-4IK002832CONDUCTIVE GEL FOR ULTRASOUND

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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