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FDA 510(k)

PACSMATE MMD-5201M MONITOR

K-Number: K101796 · 2010-07-15

Decision Date2010-07-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACSMATE MMD-5201M MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Iei Technology Corp.. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K101796. 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 PACSMATE MMD-5201M MONITOR?

PACSMATE MMD-5201M MONITOR is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Iei Technology Corp.. The 510(k) number is K101796.

When did PACSMATE MMD-5201M MONITOR receive FDA 510(k) clearance?

PACSMATE MMD-5201M MONITOR received FDA 510(k) clearance on 2010-07-15, under 510(k) number K101796.

Who is the listed applicant for PACSMATE MMD-5201M MONITOR?

The FDA 510(k) record lists Iei Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACSMATE MMD-5201M MONITOR?

The FDA product code for PACSMATE MMD-5201M MONITOR is LLZ.

Related Clinical Trials

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.

Other records listing Iei Technology Corp. 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.

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.

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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