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FDA 510(k)

PER, MODEL MEMO

K-Number: K030218 · 2003-06-23

ApplicantMedical Monitors Pty., Ltd.
Decision Date2003-06-23
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PER, MODEL MEMO is the device name listed in this FDA 510(k) record. The listed applicant is Medical Monitors Pty., Ltd.. It received FDA 510(k) clearance on 2003-06-23 under 510(k) number K030218. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PER, MODEL MEMO?

PER, MODEL MEMO is a medical device that received FDA 510(k) clearance on 2003-06-23. The listed applicant is Medical Monitors Pty., Ltd.. The 510(k) number is K030218.

When did PER, MODEL MEMO receive FDA 510(k) clearance?

PER, MODEL MEMO received FDA 510(k) clearance on 2003-06-23, under 510(k) number K030218.

Who is the listed applicant for PER, MODEL MEMO?

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

What is the FDA product code for PER, MODEL MEMO?

The FDA product code for PER, MODEL MEMO is DXH. This falls under the Hematology category.

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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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