FDA 510(k)

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011

K-Number: K010436 · 2001-05-14

ApplicantRemote Diagnostic Technologies , Ltd.

Decision Date2001-05-14

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 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 2001-05-14 under 510(k) number K010436. 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 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011?

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 is a medical device that received FDA 510(k) clearance on 2001-05-14. The listed applicant is Remote Diagnostic Technologies , Ltd.. The 510(k) number is K010436.

When did TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 receive FDA 510(k) clearance?

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 received FDA 510(k) clearance on 2001-05-14, under 510(k) number K010436.

Who is the listed applicant for TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011?

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 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011?

The FDA product code for TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 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.