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FDA 510(k)

ST-302 INFRAREX

K-Number: K990233 · 1999-10-27

ApplicantSkylark Device Co., Ltd.
Decision Date1999-10-27
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ST-302 INFRAREX 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 1999-10-27 under 510(k) number K990233. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST-302 INFRAREX?

ST-302 INFRAREX is a medical device that received FDA 510(k) clearance on 1999-10-27. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K990233.

When did ST-302 INFRAREX receive FDA 510(k) clearance?

ST-302 INFRAREX received FDA 510(k) clearance on 1999-10-27, under 510(k) number K990233.

Who is the listed applicant for ST-302 INFRAREX?

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 ST-302 INFRAREX?

The FDA product code for ST-302 INFRAREX is ILY.

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Other records listing Skylark Device Co., Ltd. as applicant

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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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