The following data is part of a premarket notification filed by Remote Diagnostic Technologies, Ltd, A Philips Company with the FDA for Tempus Ls - Manual.
| Device ID | K200849 |
| 510k Number | K200849 |
| Device Name: | Tempus LS - Manual |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | Remote Diagnostic Technologies, Ltd, A Philips Company Pavilion C2, Ashwood Park, Ashwood Way Basingstoke, GB Rg23 8bg |
| Contact | Martin Newman |
| Correspondent | Meaghan Bailey NSF Health Sciences, LLC 2001 Pennsylvania Avenue NW, Suite 950 Washington, DC 20006 |
| Product Code | LDD |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DRO |
| Subsequent Product Code | LIX |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060472441973 | K200849 | 000 |
| 05060472441966 | K200849 | 000 |
| 05060472441959 | K200849 | 000 |
| 05060472441942 | K200849 | 000 |
| 07613365002737 | K200849 | 000 |
| 05060472441539 | K200849 | 000 |
| 05060472441423 | K200849 | 000 |