Heartstart Mrx, Invasive Pressure & Temperature Options
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K061707 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HeartStart MRX Invasive Pressure and Temperature Options is an Automated External Defibrillator (Non-Wearable) designed for emergency cardiac resuscitation. It monitors heart rhythm, delivers defibrillation shocks, and provides real-time invasive pressure and temperature measurements to support advanced cardiac life support interventions.
This device is intended for use in pre-hospital and in-hospital settings by trained healthcare providers. Supplied as a reusable medical device, it requires proper calibration and maintenance in accordance with manufacturer guidelines. The HeartStart MRX is classified as a Class III device under FDA regulations (870.5310) and holds an FDA 510(k) clearance (K061707) with an abbreviated review process. It is not MRI-safe and must be stored in a clean, dry environment as specified by the manufacturer.
Frequently asked questions
What types of environments is the HeartStart MRX Invasive Pressure and Temperature Options designed for, and who should operate it?
The HeartStart MRX is specifically designed for use in both pre-hospital (e.g., ambulance settings) and in-hospital environments where advanced cardiac life support is required. It is intended for trained healthcare providers, such as paramedics, emergency medical technicians, and clinicians, who have experience in managing invasive pressure and temperature monitoring during cardiac resuscitation.
Is the HeartStart MRX a single-use or reusable device, and what maintenance does it require?
The HeartStart MRX is a reusable medical device, meaning it is not intended for single-use. To ensure accurate performance, it requires proper calibration and regular maintenance as outlined in the manufacturer’s guidelines. This includes periodic checks and servicing to maintain its functionality for invasive pressure and temperature monitoring during resuscitation efforts.
What storage conditions are recommended for the HeartStart MRX to preserve its functionality?
The device must be stored in a clean, dry environment as specified by Philips Medical Systems. Avoid exposing it to moisture, extreme temperatures, or contaminants, as these conditions could compromise its performance or calibration. Adhering to these storage guidelines helps ensure reliability during emergency cardiac resuscitation.
Does the HeartStart MRX have any special considerations regarding MRI compatibility?
No, the HeartStart MRX is explicitly not MRI-safe. This means it should never be used or stored in an MRI environment, as exposure to magnetic fields could cause malfunctions or pose safety risks. Always verify the device’s location and ensure it remains outside MRI zones when in use or storage.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061707 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (1)
- FDA 510(k) K061707 24 fields · synced Sep 18, 2026