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FDA 510(k)

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002

K-Number: K033410 · 2004-03-05

ApplicantRemote Diagnostic Technologies , Ltd.
Decision Date2004-03-05
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 is the device name listed in this FDA 510(k) record. The listed applicant is Remote Diagnostic Technologies , Ltd.. It received FDA 510(k) clearance on 2004-03-05 under 510(k) number K033410. 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 TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002?

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Remote Diagnostic Technologies , Ltd.. The 510(k) number is K033410.

When did TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 receive FDA 510(k) clearance?

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 received FDA 510(k) clearance on 2004-03-05, under 510(k) number K033410.

Who is the listed applicant for TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002?

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

What is the FDA product code for TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002?

The FDA product code for TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 is DXH. This falls under the Hematology category.

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Other records listing Remote Diagnostic Technologies , Ltd. 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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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