Tempus LS - Manual
K-Number: K200849 · 2020-07-24
Decision Date2020-07-24
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Tempus LS - Manual is a medical device manufactured by Remote Diagnostic Technologies, Ltd. A Philips Company. It received FDA 510(k) clearance on 2020-07-24 under approval 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. It is manufactured by Remote Diagnostic Technologies, Ltd. A Philips Company. The 510(k) number is K200849.
When was Tempus LS - Manual approved by the FDA?
Tempus LS - Manual received FDA 510(k) clearance on 2020-07-24, under approval number K200849.
What company makes Tempus LS - Manual?
Tempus LS - Manual is manufactured by Remote Diagnostic Technologies, Ltd. A Philips Company.
What is the FDA product code for Tempus LS - Manual?
The FDA product code for Tempus LS - Manual is LDD.
Related Devices (Code: LDD)
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.