Identifiers
- 510(k) Number
- K082789 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The G1B Pulse Oximeter is a non-invasive medical device classified as a pulse oximeter (Device Type: DQA), designed to measure oxygen saturation (SpO₂) in arterial blood and pulse rate. It employs photoplethysmography to detect light absorption variations in hemoglobin, providing real-time monitoring of oxygenation levels. The device is intended for clinical and non-clinical use to assess respiratory and circulatory function. Its digital algorithm ensures fast, accurate, and stable readings, making it suitable for diverse patient populations.
The G1B Pulse Oximeter is supplied as a handheld, reusable device with a 1.8-inch high-definition color LCD screen for displaying SpO₂ waveforms, numerical values, and perfusion index. It features at least 48 hours of data storage for oxymetry trends and pulse rate, supporting continuous patient monitoring. The device is non-sterile and intended for use in clinical settings, including hospitals, ambulances, and home care. It holds FDA 510(k) clearance under K082789, with a classification under the Cardiovascular Advisory Committee.
Frequently asked questions
What is the G1B Pulse Oximeter used for?
The G1B Pulse Oximeter is designed to non-invasively measure arterial blood oxygen saturation (SpO₂) and pulse rate using photoplethysmography. It provides real-time monitoring of oxygenation and circulatory function, making it suitable for assessing respiratory and circulatory health in clinical and non-clinical settings like hospitals, ambulances, and home care.
How is the G1B Pulse Oximeter supplied and what does it include?
The G1B Pulse Oximeter is supplied as a standalone, handheld device. It features a 1.8-inch high-definition color LCD screen that displays SpO₂ waveforms, numerical values, and the perfusion index. The device also includes at least 48 hours of data storage for oxymetry trends and pulse rate, enabling continuous patient monitoring.
Is the G1B Pulse Oximeter sterile or reusable?
The G1B Pulse Oximeter is non-sterile and designed for reuse in clinical environments. It is intended for repeated use in settings such as hospitals, ambulances, and home care, where proper cleaning and maintenance protocols must be followed to ensure accuracy and hygiene.
What display features does the G1B Pulse Oximeter offer?
The device includes a 1.8-inch high-definition color LCD screen that visually presents key metrics: SpO₂ waveforms, numerical SpO₂ values, and the perfusion index. This display format enhances usability by providing immediate, clear feedback for clinicians and caregivers during patient monitoring.
How does the G1B Pulse Oximeter store patient data?
The G1B Pulse Oximeter stores at least 48 hours of oxymetry trends and pulse rate data, allowing for continuous monitoring and trend analysis. This feature is particularly useful in clinical settings where prolonged observation of patient vitals is required, such as during surgeries, emergency care, or long-term home monitoring.
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: G1B pulse oximeter-Shenzhen General Meditech Inc., General Meditech G1B handheld pulse oximeter, Pulse oximeter with separate sensor / handheld G1B General Meditech G1B
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082789 | Class II | Active |
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Manufacturer
- Manufacturer
- General Meditech, Inc.
Sources (1)
- FDA 510(k) K082789 24 fields · synced Oct 1, 2026