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FDA 510(k)

SENTINEL

K-Number: K062397 · 2007-01-25

ApplicantDel Mar Reynolds Medical, Ltd.
Decision Date2007-01-25
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENTINEL is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Reynolds Medical, Ltd.. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K062397. 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 SENTINEL?

SENTINEL is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Del Mar Reynolds Medical, Ltd.. The 510(k) number is K062397.

When did SENTINEL receive FDA 510(k) clearance?

SENTINEL received FDA 510(k) clearance on 2007-01-25, under 510(k) number K062397.

Who is the listed applicant for SENTINEL?

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

What is the FDA product code for SENTINEL?

The FDA product code for SENTINEL is DXH. This falls under the Hematology category.

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Other records listing Del Mar Reynolds Medical, Ltd. as applicant

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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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