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510(k) Data Aggregation
K Number
K153628Device Name
ROSC-U Mini Chest Compressor (RMCC)
Manufacturer
Resuscitation International, LLC
Date Cleared
2016-01-30
(43 days)
Product Code
DRM
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
Resuscitation International, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
Device Description
The RMCC is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by a battery powered Control Unit. The RMCC provides consistent CPR support for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques.
- 1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest.
- 2. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit.
- 3. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient.
- 4. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport.
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K Number
K102068Device Name
MINIATURIZE CHEST COMPRESSOR (MCC)
Manufacturer
RESUSCITATION INTERNATIONAL
Date Cleared
2010-11-16
(116 days)
Product Code
DRM
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
RESUSCITATION INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
Device Description
The miniaturized compressor (MCC) is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by compressed oxygen or air.
The MCC provides consistent CPR support for cardiac arrest patients under conditions, which might otherwise hinder the effectiveness of manual techniques.
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