Ambu Mark IV Resuscitator
FDA 510(k)Class II (US FDA 510(k))
by Ambu A/S
Identifiers
- 510(k) Number
- K053140 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 Ambu Mark IV Resuscitator is a manual resuscitator designed for ventilation of adults and children. It features a single-shutter valve system for reliable functionality and includes a pressure-limiting valve in the baby size variant to prevent excessive pressure delivery.
The device is reusable and supplied for use in both emergency and in-hospital environments. It conforms to ASTM F 920-93(99) and EN ISO 10651-4:2002 standards and Directive 93/42/EEC concerning medical devices, with FDA 510(k) clearance under product code BTM and regulation number 868.5915.
Frequently asked questions
What is the Ambu Mark IV Resuscitator used for?
The Ambu Mark IV Resuscitator is designed for manual ventilation of adults and children in emergency and in-hospital settings, providing reliable airflow through its single-shutter valve system.
Is the Ambu Mark IV Resuscitator reusable or single-use?
The device is reusable, as stated in the description, and is supplied for repeated use in clinical environments after proper cleaning and disinfection according to manufacturer guidelines.
Does the Ambu Mark IV Resuscitator include safety features to prevent over-ventilation?
Yes, the baby size variant includes a pressure-limiting valve to prevent excessive pressure delivery, enhancing safety during pediatric ventilation.
What standards does the Ambu Mark IV Resuscitator conform to?
The device conforms to ASTM F 920-93(99) and EN ISO 10651-4:2002 standards, and meets the requirements of Directive 93/42/EEC concerning medical devices.
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: Ambu® Mark IV Reusable Resuscitator, Ambu® Mark IV DATASHEET Resuscitators, Ambu® Mark IV Resuscitators, AMBU MARK IV INSTRUCTIONS FOR USE MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053140 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA 510(k) K053140 24 fields · synced Sep 22, 2026