(28 days)
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
Not Found
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.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).