FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
age of officials' offices, nursing units, and patient care areas of ● hospitals.

Device Description

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AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the BpTRU Automated Non-Invasive Blood Pressure Monitor. It determines substantial equivalence to a predicate device and allows the device to be marketed.

However, the document does not contain any information about acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and study details based on the given input. The information necessary to answer the prompt is not present in the provided FDA letter.

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K Number

K002046

Device Name

MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

Manufacturer

VSM TECHNOLOGY, INC.

Date Cleared

2000-07-21

(16 days)

Product Code