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The air compressor for use with a nebulizer is a device intended to provide a source of compressed air to nebulizer medication cups and delivery systems. These air compressors have a flowrate of 11 +/- 2 LPM, minimum pressure of 35 psi, a storage temperature of 5 C to 50 C (41F to 122F) and a operating temperature 10 C to 40 C ( 50 F to 104 F).

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The provided text is a 510(k) premarket notification approval letter for a medical device (air compressor for use with a nebulizer). It does not contain information about acceptance criteria for a study, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

The document primarily focuses on:

• Device Name: Schuco Mist and Schuco Deluxe Mist (Trade/Device Name), and AIR COMPRESSOR FOR USE WITH A NEBULIZER (Indicated Device Name).
• Regulation Number: 21 CFR 868.5630 (Nebulizer).
• Regulatory Class: II.
• FDA's finding: Substantial equivalence to legally marketed predicate devices.
• Indications for Use: "The air compressor for use with a nebulizer is a device intended to provide a source of compressed air to nebulizer medication cups and delivery systems. These air compressors have a flowrate of 11 +/- 2 LPM, minimum pressure of 35 psi, a storage temperature of 5 C to 50 C (41F to 122F) and an operating temperature 10 C to 40 C ( 50 F to 104 F)."
• Prescription Use: Yes.

To answer your specific questions, information about acceptance criteria, study details, and data specifics would need to be found in a separate performance study report or clinical trial documentation, which is not part of this 510(k) approval letter. The document only lists the technical specifications the device has (flowrate, pressure, temperatures) as part of its Indications for Use, but these are not presented as "acceptance criteria" against which a study's results are compared in this text.

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