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The device is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an alarm triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

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This document is a 510(k) clearance letter for the Braemar Fusion Wireless Ambulatory ECG Arrhythmia Monitor System. It does not contain information about acceptance criteria or the study that proves the device meets them. It primarily states that the device is substantially equivalent to a predicate device and can thus be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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The DL900 Series Holter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below:

• Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
• Evaluation of patients for ST segment changes.
• Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
• Clinical and epidemiological research studies.
• Evaluation of patients with pacemakers.
• Reporting of time and frequency domain heart rate variability.
• Reporting of QT Interval

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I am sorry, but the provided text does not contain information about the acceptance criteria for the Braemar DL900 Series Holter Recorder or any studies conducted to prove the device meets such criteria. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and supporting studies.

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The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.

Braemar ER900 Series Enhanced Algorithm ECG Event Recorder

The provided text is a 510(k) premarket notification letter from the FDA to Braemar, Inc. regarding their ER900 Series Enhanced Algorithm ECG Event Recorder. This document does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on its substantial equivalence to a predicate device, not necessarily through a formal study with detailed acceptance criteria and performance metrics described in this specific document. The FDA's 510(k) pathway often relies on demonstrating equivalence rather than requiring extensive clinical trials with predefined performance endpoints for novel devices.

Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text. The information regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, and ground truth establishment would typically be found in the manufacturer's 510(k) submission, which is a much more extensive document than the FDA's clearance letter.

Ask a specific question about this device

The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.

Braemar ER800 Series Enhanced Algorithm Event Recorder

This document is a 510(k) clearance letter from the FDA for the Braemar ER800 Series Enhanced Algorithm Event Recorder. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance and does not include technical or clinical study data.

Ask a specific question about this device