510(k) K200849 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Tempus LS - Manual
| Applicant | Remote Diagnostic Technologies, Ltd. A Philips Company, Basingstoke, GB |
| Decision | Substantially Equivalent, Jul 24, 2020 |
| Received | Mar 31, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200849
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2024 | Remote Diagnostic Technologies Ltd. Tempus LS-Manual Defibrillator Model 00-3020
The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode Open, Classified |
LDD | None listed |
| Jun 6, 2024 | Remote Diagnostic Technologies Ltd. Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual Open, Classified |
LDD | None listed |
| Jun 12, 2023 | Remote Diagnostic Technologies Ltd. Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 Open, Classified |
LDD | None listed |
| Dec 11, 2020 | Remote Diagnostic Technologies Ltd. Tempus LS - Manual Defibrillator, Model Number: 00-3020
Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and Terminated |
LDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.