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510(k) Data Aggregation
K Number
K131790Device Name
A9800 ANESTHESIA WORKSTATION
Manufacturer
ORICARE, INC.
Date Cleared
2014-05-09
(325 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
ORICARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A9800 Anesthesia Workstation provides general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment. The device is indicated for volume or pressure control ventilation.
Device Description
The A9800 Anesthesia Workstation provides accurate, pneumatically driven and electronically controlled ventilation. The A9800 includes modes that provide patient-appropriate defaults and ranges. The A9800 was rigorously tested to harmonized standards, which included a full human factors study with physicians. Like the predicate device (K123125) A9800 provides complete anesthesia ventilation capabilities that include traditional and "intensive care type" ventilation modes. Low-flow anesthesia delivery creates savings by lower facility gas usage. The integrated electronic flow meter provides accurate monitoring and intuitive operation. The A9800 bellows contains breathing gasses to be delivered to the patient as does the predicate device. Likewise, for patient safety both the predicate and the A9800 maintain positive pressure in the breathing system so any leakage that occurs is outward. PEEP (Positive End Expiratory Pressure) in A9800 is electronically regulated for patient safety and is substantially equivalent to the predicate device. Both the A9800 and the predicate device offer an ACGO (alternate common gas outlet) to provide fresh gas to non-rebreathing adapters. The A9800 and the predicate device (K123125) include the following ventilation modes: Volume Mode, Pressure Control Mode, Pressure Support Mode with Apnea Backup, Synchronized Intermittent Mandatory Ventilation Mode (SIMV), and Pressure Controlled Ventilation with Volume Guarantee (PCV-VG). The predicate offers SIMV-PCV-VG, which is not offered on the A9800. The A9800 method of control, of the maximum applied breathing pressure, during manual ventilation (by using a single turn APL valve along with a manual breathing bag) is equivalent to the predicate device. Both the predicate device (K123125) and the A9800 have an accessory gas analyzer that can monitor FiO2 and patient respiratory gas for CO2, N2O, and five types of anesthetic agents. A9800 and the predicate also have an Anesthetic Gas Scavenging System (AGSS) for the safe and effective removal of waste gas. Both the predicate device (K123125) and the A9800 utilize a large 15 inch touch screen monitor with a navigator wheel that provides a simple intuitive interface for user control. The screen can be tilted upward and downward according to the doctor's needs and position. The parameter areas on the main screen are shown in different colors for ease of identification. The waveforms and alarm records are clearly shown for easy review by the clinician. Like the predicate device (K123125) the A9800 displays patient data with waveforms and spirometry loops. A reference loop can be stored to best understand changes in patient response to therapy. Both the A9800 and its predicate device (K123125) contain electronic flow meters for Oz, Air, and NzO, which are designed especially for low flow applications. Electronic fresh gas flow displays are used in addition to traditional mechanical flow controllers for enhanced patient safety. Data communications export is supported to connect to the Hospital IT systems and support electronic medical records (EMR).
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K Number
K120931Device Name
CRITICAL CARE VENTILATOR
Manufacturer
ORICARE, INC.
Date Cleared
2013-06-06
(436 days)
Product Code
CBK, BTI, BTT, CCK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
ORICARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.
The V8800 Critical Care Ventilator may be used by trained professional health care providers under the supervision of a physician.
The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation.
The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.
The V8800 Crtical Care Ventilator is intended for use in hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.
Device Description
The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.
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K Number
K122875Device Name
ORICARE L2700
Manufacturer
ORICARE, INC.
Date Cleared
2012-12-18
(90 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ORICARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oricare L2700 Series Surgical Lamps provide illumination at varying illumination levels to the patient surgical area and provide video-visual procedural support for medical staff during surgical procedures.
Device Description
OL 2700 series Surgical Lamps are ceiling mounted Surgical Lamps, suitable for providing supplemental illumination, with reduced shadowing effects during surgical and non-surgical procedures. The lighting system utilizes LED's for illumination and is powered from a standard 115VAC voltage source. The head design is comprised of multiple LED's (Light Emitting Diodes). It provides a cool, color corrected light which is adjustable with 10 levels of intensity. The light path design provides an extended light depth so that the beam requires no manual focus. Light generated by the LEDs is focused by optical lens to achieve an ideal irradiance pattern. The OL 2700 series LED surgical light can be configured with one or two light heads, the primary light head is useful for major illumination while the secondary light head is for ancillary illumination. The lights can also provide low level background lighting for endoscopic surgery. Oricare L2700 series Operating Room Lamps can be easily used in conjunction with the optional SD or HD video systems, to document surgical procedures for training purposes, make use of live transmissions or consult with external surgeons during operations. The camera system is available in different versions and can be used with integrated OR systems. It delivers images in SD or HD quality straight to the TFT monitor.
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K Number
K113338Device Name
MEDICAL AIR COMPRESSOR
Manufacturer
ORICARE, INC.
Date Cleared
2012-08-10
(270 days)
Product Code
BTI
Regulation Number
868.6250Why did this record match?
Applicant Name (Manufacturer) :
ORICARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator that operates within the C4500 Compressor manufacturer specifications.
Device Description
The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for medical
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