(8 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 8 inches to 13 inches (20 cm 33 cm).
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This document is a marketing authorization letter for the Omron Healthcare, Inc. Model HEM-906 Oscillometric Digital Blood Pressure Monitor, and it does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them.
The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about any specific study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).
The "Indications for Use Statement" (page 2) describes the intended use of the device but does not specify performance metrics or study results.
To obtain the information you're looking for, you would typically need to consult the original 510(k) submission
summary or the full 510(k) submission provided by Omron Healthcare, Inc. to the FDA, which would contain the
technical and clinical data supporting the substantial equivalence claim.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).