Identity
- Trade Name
- MODEL 9310 LUNG WATER COMPUTER FDA PMA
- Generic Name
- MONITOR, LUNG WATER MEASUREMENT FDA PMA
Identifiers
- PMA Number
- P800003 FDA PMA
- FDA Product Code
- JEZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 868.2450 FDA PMA
- Regulation Number
- 868.2450 FDA PMA
- Advisory Committee
- Anesthesiology FDA PMA
- FDA Decision
- APWD FDA PMA
The Model 9310 Lung Water Computer is a Monitor, Lung Water Measurement device, classified as a Class III medical device under FDA regulation 868.2450. It is designed to measure lung water levels, providing critical data for monitoring patients during anesthesia and intensive care procedures. This measurement aids clinicians in assessing pulmonary edema and fluid balance in real-time.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as operating rooms and intensive care units. It operates in conjunction with other monitoring systems and requires proper calibration and maintenance as specified by the manufacturer. Authorized under FDA PMA (P800003), the Model 9310 adheres to regulatory standards for Class III devices, ensuring compliance with safety and performance requirements.
Frequently asked questions
What clinical setting is the Model 9310 Lung Water Computer primarily used in, and how does it assist clinicians?
The Model 9310 is designed for use in operating rooms and intensive care units, where it measures lung water levels in real-time. This helps clinicians monitor patients during anesthesia and critical care by assessing pulmonary edema and fluid balance, enabling timely adjustments to patient treatment.
Is the Model 9310 Lung Water Computer intended for single-use or reusable applications, and what does this mean for maintenance?
The Model 9310 is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings. Since it is reusable, proper calibration and maintenance—following the manufacturer’s guidelines—are essential to ensure accurate lung water measurements and device reliability over time.
How does the Model 9310 Lung Water Computer integrate with other medical systems, and what role does it play in patient monitoring?
The Model 9310 operates in conjunction with other monitoring systems to provide critical lung water data. It measures fluid accumulation in the lungs, which is particularly useful for assessing pulmonary edema and guiding fluid management decisions during anesthesia and intensive care, ensuring safer patient outcomes.
What regulatory pathway was followed for the Model 9310, and what does this indicate about its compliance standards?
The Model 9310 was authorized through the FDA’s Premarket Approval (PMA) process under PMA number P800003, reflecting its classification as a Class III device. This pathway ensures the device meets stringent safety and performance requirements, as mandated by FDA regulation 868.2450 for lung water measurement monitors.
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. Sources consulted: Modell Rechtschreibung, Bedeutung, Definition, Herkunft Duden
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P800003 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P800003 24 fields · synced Sep 18, 2026