510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200849Substantially Equivalent

Tempus LS - Manual

Remote Diagnostic Technologies, Ltd. A Philips Company, Basingstoke, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200849 is the FDA 510(k) clearance record for Tempus LS - Manual, a class II device, cleared for Remote Diagnostic Technologies, Ltd. A Philips Company on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list one 510(k) clearance for Remote Diagnostic Technologies, Ltd. A Philips Company. As of , FDA records show 4 recalls naming K200849.

Clearance record

Decision date
Received
(115 days to decision)
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
Remote Diagnostic Technologies, Ltd. A Philips Company Pavilion C2, Ashwood Park, Ashwood Way, Basingstoke, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LDD

Trailing 12 months

FDA records hold no clearances under product code LDD in the trailing twelve months.

FDA records show no clearances under product code LDD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260