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FDA 510(k)

SDS-4I

K-Number: K034005 · 2004-11-18

ApplicantSkylark Device & Systems Co., Ltd.
Decision Date2004-11-18
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SDS-4I 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 2004-11-18 under 510(k) number K034005. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDS-4I?

SDS-4I is a medical device that received FDA 510(k) clearance on 2004-11-18. The listed applicant is Skylark Device & Systems Co., Ltd.. The 510(k) number is K034005.

When did SDS-4I receive FDA 510(k) clearance?

SDS-4I received FDA 510(k) clearance on 2004-11-18, under 510(k) number K034005.

Who is the listed applicant for SDS-4I?

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 SDS-4I?

The FDA product code for SDS-4I is IPF.

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-100IRK002832CONDUCTIVE GEL FOR ULTRASOUNDK992652SD-730 IF-SDS, PERFECT PULSE IF-SDS

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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