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To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.

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This document is a 510(k) clearance letter from the FDA for manual resuscitators. It does not contain information about acceptance criteria, study details, or device performance metrics. Therefore, it's impossible to fill in the requested table and details based solely on the provided text.

The document primarily focuses on:

• Device Identification: PVC Manual Resusciator (DA-00131, DA-00132, DA-00133) and Silicone Manual Resusciator (DA-00171, DA-00172, DA-00173).
• Regulatory Information: Classification as Class II, Regulation Number 21 CFR 868.5915, Product Code BTM.
• Intended Use: "To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate."
• FDA's Determination: Substantial equivalence to legally marketed predicate devices.

To provide the requested information, a separate document describing the clinical study or performance testing conducted for these devices would be necessary.

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