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TO PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT IN PUT.

THE SENSOR ANPLIFIER IS TO BE USED WITH SUBTETS (CHILDRING E ADVES) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGHER INPUT SIGNAL , THE DOVE IS INFENDED FOR SLOUD LABS.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any study conducted for the "Sensor Amplifier" device.

The provided document is an FDA 510(k) clearance letter from October 2, 1997. This type of letter primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically include detailed performance study results or specific acceptance criteria.

The document mentions:

• Trade Name: Sensor Amplifier
• Regulatory Class: II
• Product Code: 84GWL
• Indications For Use: "TO PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT IN PUT. THE SENSOR ANPLIFIER IS TO BE USED WITH SUBJECTS (CHILDREN & ADULTS) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGHER INPUT SIGNAL, THE DEVICE IS INTENDED FOR SLEEP LABS."

To answer your request, a different type of document, such as a full clinical study report, a design verification report, or a comprehensive premarket submission summary, would be needed.

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