Cleared Traditional

Tempus LS - Manual

K200849 · Remote Diagnostic Technologies, Ltd. A Philips Company · Cardiovascular

Jul 2020

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K200849 is an FDA 510(k) clearance for the Tempus LS - Manual, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Remote Diagnostic Technologies, Ltd. A Philips Company (Basingstoke, GB). The FDA issued a Cleared decision on July 24, 2020, 115 days after receiving the submission on March 31, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number	K200849 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2020
Decision Date	July 24, 2020
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF