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FDA 510(k)

PACSMATE, MODEL MMD-4300C/MMD-4300CX

K-Number: K091687 · 2009-07-07

ApplicantIei Technology Corp.
Decision Date2009-07-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACSMATE, MODEL MMD-4300C/MMD-4300CX 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 2009-07-07 under 510(k) number K091687. 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, MODEL MMD-4300C/MMD-4300CX?

PACSMATE, MODEL MMD-4300C/MMD-4300CX is a medical device that received FDA 510(k) clearance on 2009-07-07. The listed applicant is Iei Technology Corp.. The 510(k) number is K091687.

When did PACSMATE, MODEL MMD-4300C/MMD-4300CX receive FDA 510(k) clearance?

PACSMATE, MODEL MMD-4300C/MMD-4300CX received FDA 510(k) clearance on 2009-07-07, under 510(k) number K091687.

Who is the listed applicant for PACSMATE, MODEL MMD-4300C/MMD-4300CX?

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, MODEL MMD-4300C/MMD-4300CX?

The FDA product code for PACSMATE, MODEL MMD-4300C/MMD-4300CX is LLZ.

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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.

K101796PACSMATE MMD-5201M MONITORK082496PACSMATE MMD-3213M MONITOR

Related Devices (Code: LLZ)

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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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