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THE CARDIOBEEPER CB250 IS INDICATED FOR USE BY THE PATIENT IN TRANSMITTING ECG INFORMATION FROM A REMOTE LOCATION To A RECEIVING CENTER.

The CardioBeeper ® CB250 is a single-lead, compact, hand-held, battery powered, personal transtelephonic ECG transmitter enclosed in a billfold wallet. The device has been designed to enable the user to transmit a rhythm strip to a central receiving station using acoustic coupling. The ECG information is transmitted as a frequency modulation of the basic 1700Hz tone. The device is sealed (not hermetically) for life. There are no user-servicable parts inside. The batteries are not replaceable and the unit should be discarded after depletion.

The provided text describes a 510(k) summary for the Meridian Medical Technologies Ltd CardioBeeper® CB250. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for AI/software devices. Therefore, much of the requested information cannot be directly extracted from this type of regulatory submission.

However, based on the information available, here's a breakdown of what can be inferred or stated as not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a formal table of acceptance criteria and reported device performance in the way a clinical study report would. Instead, it focuses on demonstrating substantial equivalence based on design comparisons and technical specifications to legally marketed predicate devices.

The "performance" is implicitly deemed acceptable if the device's technical specifications are comparable to or improved over the predicate devices. The table provided (on page 1) is a comparison of technical specifications between the CardioBeeper® CB250 and two predicate devices (CardioBeeper® CB12L and CardioBeeper® CBII).

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