Bageasy(r) Iii Child/Infant Dispos Man Resuscitators
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K940581 FDA 510(k)
- FDA Product Code
- BTM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5915 FDA 510(k)
- Regulation Number
- 868.5915 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bageasy III Child/Infant Disposable Manual Resuscitator is a manual emergency ventilator. It is designed to provide respiratory support for pediatric and infant patients.
This device is supplied as a single-use, disposable unit. It has received FDA 510(k) clearance under product code BTM and is classified as a Class II medical device.
Frequently asked questions
What is the primary purpose of the Bageasy III?
The Bageasy III is a manual emergency ventilator designed to provide respiratory support specifically for pediatric and infant patients.
Is this device intended for multiple uses?
No, the Bageasy III is supplied as a single-use, disposable unit to ensure patient safety and prevent cross-contamination.
What is the regulatory status of this resuscitator?
The Bageasy III has received FDA 510(k) clearance under product code BTM and is classified as a Class II medical device.
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: Bageasy (R) Iii Child/Infant Dispos Man Resuscitators, BAGEASY (R) III CHILD/INFANT DISPOS MAN ... (K940581) - FDA 510 (k), PDF K940581 Bageasy(R) Iii Child/Infant Dispos Man Resuscitators
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940581 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K940581 24 fields · synced Sep 24, 2026