Device Classification Name |
dc-defibrillator, low-energy, (including paddles)
|
510(k) Number |
K200849 |
Device Name |
Tempus LS - Manual |
Applicant |
Remote Diagnostic Technologies, Ltd, a Philips Company |
Pavilion C2, Ashwood Park, Ashwood Way |
Basingstoke,
GB
RG23 8BG
|
|
Applicant Contact |
Martin Newman |
Correspondent |
NSF Health Sciences, LLC |
2001 Pennsylvania Avenue NW, Suite 950 |
Washington,
DC
20006
|
|
Correspondent Contact |
Meaghan Bailey |
Regulation Number | 870.5300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/31/2020 |
Decision Date | 07/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|