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FDA 510(k)

SD-605 SD II PROGRAM

K-Number: K923935 · 1992-10-15

ApplicantSkylark Device Co., Ltd.
Decision Date1992-10-15
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SD-605 SD II PROGRAM 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 1992-10-15 under 510(k) number K923935. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SD-605 SD II PROGRAM?

SD-605 SD II PROGRAM is a medical device that received FDA 510(k) clearance on 1992-10-15. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K923935.

When did SD-605 SD II PROGRAM receive FDA 510(k) clearance?

SD-605 SD II PROGRAM received FDA 510(k) clearance on 1992-10-15, under 510(k) number K923935.

Who is the listed applicant for SD-605 SD II PROGRAM?

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 SD-605 SD II PROGRAM?

The FDA product code for SD-605 SD II PROGRAM is GZJ.

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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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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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