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An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers.

An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge.

The provided text is a 510(k) Pre-Market Notification from the FDA concerning an ABN Aneroid Sphygmomanometer. This document is a regulatory approval for the device based on its substantial equivalence to a legally marketed predicate device.

It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily states:

• The device's trade name: ABN Aneroid Sphygmomanometer
• Its regulation number: 21 CFR 870.1120
• Its regulatory class: Class II (two)
• Its product code: 78 DXQ
• The date of receipt and approval.
• The FDA's determination of substantial equivalence to a predicate device.
• Indications for Use: "An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the blood pressure of a patient by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. This type of information would typically be found in a separate study report or a detailed technical submission, not in this specific FDA approval letter.

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