FDA 510(k)

Tempus LS - Manual

K-Number: K200849 · 2020-07-24

ApplicantRemote Diagnostic Technologies, Ltd. A Philips Company

Decision Date2020-07-24

Product CodeLDD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Tempus LS - Manual is the device name listed in this FDA 510(k) record. The listed applicant is Remote Diagnostic Technologies, Ltd. A Philips Company. It received FDA 510(k) clearance on 2020-07-24 under 510(k) number K200849. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tempus LS - Manual?

Tempus LS - Manual is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is Remote Diagnostic Technologies, Ltd. A Philips Company. The 510(k) number is K200849.

When did Tempus LS - Manual receive FDA 510(k) clearance?

Tempus LS - Manual received FDA 510(k) clearance on 2020-07-24, under 510(k) number K200849.

Who is the listed applicant for Tempus LS - Manual?

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

What is the FDA product code for Tempus LS - Manual?

The FDA product code for Tempus LS - Manual is LDD.

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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.