Tempus LS - Manual— 510(k) K200849
Substantially EquivalentRemote Diagnostic Technologies, Ltd. A Philips Company
FDA 510(k) clearance K200849 for Tempus LS - Manual, Substantially Equivalent on 2020-07-24. Applicant: Remote Diagnostic Technologies, Ltd. A Philips Company. Device class: 2.
Clearance details
- Applicant
- Remote Diagnostic Technologies, Ltd. A Philips Company
- Product code
- Code LDD
- Device class
- Class 2
- Regulation
- 21 CFR 870.5300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Basingstoke, GB
Recent devices under product code LDD
view allAdverse events under product code LDD
product code LDD- Death
- 38
- Malfunction
- 522
- Total
- 560
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200849
K-number listed on FDA's recall record- Z-0557-2025 — Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
- Z-2028-2024 — Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
- Z-1825-2023 — Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Z-0564-2021 — 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 transport applications (including ambulances, fixed and rotary wing aircraft).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200849.
Data sourced from openFDA. This site is unofficial and independent of the FDA.