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510(k) Data Aggregation
K Number
K011901Device Name
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
Manufacturer
SURVIVALINK CORP.
Date Cleared
2002-02-01
(228 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
SURVIVALINK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FirstSave STAR Biphasic AED is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. The device is intended for use on persons older than eight years of age.
Device Description
The FirstSave STAR Biphasic AED is a biphasic portable battery operated semiautomatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic feature includes: Lithium battery, Single user button for Rescue or Resume, LED diagnostic panel, Non-volatile status indicator, Voice prompts, Biphasic truncated exponential defibrillation waveform, RhythmX ECG analysis algorithm.
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K Number
K010214Device Name
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
Manufacturer
SURVIVALINK CORP.
Date Cleared
2001-02-22
(30 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
SURVIVALINK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993072Device Name
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
Manufacturer
SURVIVALINK CORP.
Date Cleared
1999-12-10
(87 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
SURVIVALINK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.
The electrodes are intended for short-term use (< 8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.
Device Description
The SVL-9630 electrodes consists of a pair of non sterile, hydrogel polymeric selfadhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
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K Number
K982264Device Name
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
Manufacturer
SURVIVALINK CORP.
Date Cleared
1999-01-25
(210 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
SURVIVALINK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FirstSave STAR Biphasic AED is designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias for patients older than eight years old. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device.
Device Description
The FirstSave STAR Biphasic AED is a portable battery operated semi-automatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic AED feature includes:
- . Biphasic defibrillation waveform
- . Lithium battery and battery fuel gauge
- Single user button .
- LED diagnostic panel ●
- Non-volatile status indicator ●
- Voice prompts .
The device weighs 7.4 lbs including battery, and electrodes with dimensions of 3.3in x 10.6in x 12.4in.
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K Number
K970481Device Name
V2
Manufacturer
SURVIVALINK CORP.
Date Cleared
1997-07-01
(141 days)
Product Code
LDD
Regulation Number
870.5300Why did this record match?
Applicant Name (Manufacturer) :
SURVIVALINK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V2 semi-automatic external defibrillator is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The V2 is intended to be used on patients who weighs more than 90 lbs.
Device Description
FIRST SAVE AUTOMATED EXTERNAL DEFIBRILLATOR (formerly V2) Models 9100/9110
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K Number
K971149Device Name
SVL-9130 DEFIBRILLATION ELECTRODE
Manufacturer
SURVIVALINK CORP.
Date Cleared
1997-06-23
(87 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
SURVIVALINK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs.
The electrodes are intended for short term use and must be used before the expiration date listed on the packaging.
The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
Device Description
The SVL-9130 electrodes consists of a pair of hydrogel polymeric self-adhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
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