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The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs:

• Blood Oxygenation (SpO2) measurement .
• Temperature measurement
• Non Invasive Blood Pressure (NIBP) measurement .
• Heart Rate derived from selected source (SpO2, NIBP)
  The target populations are adult, pediatric and neonate populations. The monitor is intended for use within the health care facility setting.

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The provided document is a 510(k) clearance letter from the FDA for the Datascope Accutorr® Plus Non Invasive Blood Pressure Monitor. It confirms the device's substantial equivalence to a predicate device but does not contain the detailed acceptance criteria or a study proving the device meets those criteria.

The letter mentions "indications for use stated in the enclosure," but the enclosure itself (which would contain such information) is not provided in the text. The only "Indications for Use Statement" present briefly lists the vital signs the device monitors and the target populations/setting but does not include any performance metrics or acceptance criteria.

Therefore,Based on the information provided, it is not possible to complete the requested table and study details. The document is an FDA clearance letter and does not contain the technical performance specifications or details of a study that would demonstrate the device meets acceptance criteria.

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