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510(k) Data Aggregation
K Number
K081444Device Name
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
Manufacturer
BRAEMAR, INC.
Date Cleared
2008-07-31
(70 days)
Product Code
DSI, DRG
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
BRAEMAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
Not Found
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K Number
K072008Device Name
BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
Manufacturer
BRAEMAR, INC.
Date Cleared
2007-10-03
(72 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
BRAEMAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K071733Device Name
DL900 SERIES HOLTER RECORDER
Manufacturer
BRAEMAR, INC.
Date Cleared
2007-07-24
(28 days)
Product Code
MWJ
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
BRAEMAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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
Device Description
Not Found
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K Number
K071011Device Name
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
Manufacturer
BRAEMAR, INC.
Date Cleared
2007-04-27
(17 days)
Product Code
MWJ, WMJ
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
BRAEMAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
Braemar ER900 Series Enhanced Algorithm ECG Event Recorder
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K Number
K042469Device Name
BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
Manufacturer
BRAEMAR, INC.
Date Cleared
2004-10-06
(23 days)
Product Code
MWJ
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
BRAEMAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
Braemar ER800 Series Enhanced Algorithm Event Recorder
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