FDA 510(k) Premarket Notification K200849: Tempus LS - Manual

Submission Details & Decision

Normalized public record details for 510(k) notification K200849.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K200849

Applicant / Sponsor

Remote Diagnostic Technologies, Ltd. A Philips Company

Device Name

Tempus LS - Manual

Product Code

LDD

Decision Date

2020-07-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2020-03-31

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Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.