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FDA 510(k)

PACSPARTNER

K-Number: K042311 · 2004-09-09

ApplicantMedical Standard Co., Ltd.
Decision Date2004-09-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACSPARTNER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Standard Co., Ltd.. It received FDA 510(k) clearance on 2004-09-09 under 510(k) number K042311. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACSPARTNER?

PACSPARTNER is a medical device that received FDA 510(k) clearance on 2004-09-09. The listed applicant is Medical Standard Co., Ltd.. The 510(k) number is K042311.

When did PACSPARTNER receive FDA 510(k) clearance?

PACSPARTNER received FDA 510(k) clearance on 2004-09-09, under 510(k) number K042311.

Who is the listed applicant for PACSPARTNER?

The FDA 510(k) record lists Medical Standard Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACSPARTNER?

The FDA product code for PACSPARTNER is LLZ.

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Other records listing Medical Standard 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.

K083658PACS PLUS 5TH EDITIONK023460PACSPLUS

Related Devices (Code: LLZ)

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.

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