FDA 510(k)

PGS123 AND HVS-123

K-Number: K946299 · 1995-06-26

Decision Date1995-06-26

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PGS123 AND HVS-123 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 1995-06-26 under 510(k) number K946299. 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 PGS123 AND HVS-123?

PGS123 AND HVS-123 is a medical device that received FDA 510(k) clearance on 1995-06-26. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K946299.

When did PGS123 AND HVS-123 receive FDA 510(k) clearance?

PGS123 AND HVS-123 received FDA 510(k) clearance on 1995-06-26, under 510(k) number K946299.

Who is the listed applicant for PGS123 AND HVS-123?

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 PGS123 AND HVS-123?

The FDA product code for PGS123 AND HVS-123 is GZJ.

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.