CARDIOSERV S
Device Facts
| Record ID | K962551 |
|---|---|
| Device Name | CARDIOSERV S |
| Applicant | Marquette Electronics, Inc. |
| Product Code | LDD · Cardiovascular |
| Decision Date | Nov 19, 1996 |
| Decision | ST |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia. ◆ CardioServ is intended to be used by trained operators ◆ CardioServ is designed for external and internal defibrillation (including cardioversion) ◆ CardioServ is capable of monitoring the heart rate with adjustable alarm limits. ◆ CardioServ is capable of monitoring the saturation of O₂ with adjustable alarm limits. The intended use of CardioServ is identical to the intended use of the predicate devices.
Device Story
Portable defibrillator with integrated ECG monitor, recorder, and pulse oximeter; used by trained operators for emergency resuscitation and cardiac dysrhythmia management. Device performs external and internal defibrillation/cardioversion; monitors heart rate and O2 saturation with adjustable alarm limits. Output provided via integrated recorder and visual/audible alarms to assist clinicians in immediate cardiac intervention. Benefits include rapid rhythm assessment and therapeutic shock delivery.
Clinical Evidence
Bench testing only. Compliance demonstrated with ANSI/AAMI DF2-1989, ANSI/AAMI ES1-1993, IEC 606-1, IEC 601-1-1, IEC 601-2-4, and prEN865. Quality assurance included requirements reviews, code inspections, hardware/software testing, safety/environmental testing, and independent final validation.
Technological Characteristics
Portable defibrillator/monitor/oximeter. Standards: ANSI/AAMI DF2-1989, ANSI/AAMI ES1-1993, IEC 606-1, IEC 601-1-1, IEC 601-2-4, prEN865. Features integrated recorder, ECG monitoring, and O2 saturation monitoring. Technology identical to predicate devices.
Indications for Use
Indicated for emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia in patients requiring defibrillation, cardioversion, heart rate monitoring, or oxygen saturation monitoring.
Regulatory Classification
Identification
Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.
Predicate Devices
- HELLIGE CardioServ SCP 910
- NELLCOR Escort 300
Related Devices
- K962547 — CARDIOSERV P · Marquette Electronics, Inc. · Mar 6, 1997
- K100654 — ZOLL PROPAQ MD · Zoll Medical Corporation, World Wide Headquarters · Jul 29, 2010
- K112761 — ZOLL PROPAQ MD · Zoll Medical Corporation, World Wide Headquarters · Apr 25, 2012
- K133269 — ZOLL X SERIES · Zoll Medical Corporation, World Wide Headquarters · May 22, 2014
- K052316 — POWERHEART ECD · Cardiac Science, Inc. · Jan 3, 2006
