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FDA 510(k)

PEPER

K-Number: K060297 · 2006-08-02

ApplicantMedical Monitors, Ltd.
Decision Date2006-08-02
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PEPER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Monitors, Ltd.. It received FDA 510(k) clearance on 2006-08-02 under 510(k) number K060297. 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 PEPER?

PEPER is a medical device that received FDA 510(k) clearance on 2006-08-02. The listed applicant is Medical Monitors, Ltd.. The 510(k) number is K060297.

When did PEPER receive FDA 510(k) clearance?

PEPER received FDA 510(k) clearance on 2006-08-02, under 510(k) number K060297.

Who is the listed applicant for PEPER?

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

What is the FDA product code for PEPER?

The FDA product code for PEPER 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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