Browser (Event Software) Model 4500E
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K982550 FDA 510(k)
- FDA Product Code
- BZQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- ST FDA 510(k)
The Browser (Event Software) Model 4500E is a Windows 95-based software application categorized as a Monitor, Breathing Frequency device. It is designed to review and analyze physiological data, including patient information, equipment parameters, compliance logs, and event logs such as apnea, bradycardia, tachycardia, and oxygen desaturation. The software interfaces with data recorded by compatible monitoring systems, enabling detailed clinical assessment.
This software is intended for use in clinical environments to analyze patient monitoring data transferred via direct cable, modem, or storage media (e.g., floppy disks or cards). It is classified as a Class II medical device under FDA regulation (868.2375) and holds FDA 510(k) clearance (K982550) for substantial equivalence, subject to tracking. The device is not sterile or single-use and operates under the Anesthesiology advisory committee’s purview.
Browser (Event Software) Model 4500E
Frequently asked questions
What is the Browser (Event Software) Model 4500E used for?
The Browser (Event Software) Model 4500E is a Windows 95-based application designed to review and analyze physiological data from patient monitoring systems. It assesses event logs such as apnea, bradycardia, tachycardia, and oxygen desaturation, along with patient information and equipment parameters. This software helps clinicians perform detailed clinical assessments by interfacing with data recorded by compatible monitoring systems.
How is the Browser 4500E software supplied and does it require sterilization?
The Browser 4500E is supplied as a software application installed on a Windows 95-compatible system. Since it is a digital application, it does not require sterilization. It is intended for use in clinical environments and operates independently of physical hardware beyond the necessary computing infrastructure.
Is the Browser 4500E software single-use or reusable?
The Browser 4500E software is reusable and designed for repeated use in clinical settings. It is not a single-use device, as it operates on a computer system and can analyze multiple sets of patient data over time without disposal.
What types of data transfer methods does the Browser 4500E support?
The Browser 4500E supports data transfer via direct cable connections, modems, or storage media such as floppy disks or cards. This flexibility allows clinicians to retrieve and analyze patient monitoring data from various sources, ensuring comprehensive review capabilities.
What regulatory pathway does the Browser 4500E follow?
The Browser 4500E is classified as a Class II medical device under FDA regulation (868.2375) and holds FDA 510(k) clearance (K982550) for substantial equivalence, subject to tracking. It falls under the purview of the Anesthesiology advisory committee and is intended for use in clinical environments to analyze physiological data.
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: BROWSER (EVENT SOFTWARE) MODEL # 4500E by RESPIRONICS, INC. | FDA 510 ..., K982550 FDA 510(k) - BROWSER (EVENT SOFTWARE) MODEL # 4500E, BROWSER (EVENT SOFTWARE) MODEL # 4500E - Innolitics, Browser (event Software) Model # 4500e 510(k) FDA Premarket ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982550 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K982550 24 fields · synced Oct 1, 2026