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510(k) Data Aggregation
K Number
K072420Device Name
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
Manufacturer
OCEANIC MEDICAL PRODUCTS, INC.
Date Cleared
2008-01-22
(147 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
OCEANIC MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Magellan-2200, Model-3 Anesthesia Machine is intended/indicated for spontaneous or manually assisted ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and source oxygen pressure.
Device Description
The Model-3 is a gas machine for anesthesia or analgesia. The device consists of the following components: an inlet gas manifold for oxygen and air; pressure gauges for oxygen and air; a low-pressure alarm for inlet oxygen surveillance; an oxygen analyzer and monitor; an oxygen flow selector for nasal cannula or oxygen mask for pre- and post-anesthesia use; an oxygen flush button; oxygen and air flowmeters; an agent-specific vaporizer; a common gas outlet; a carbon dioxide absorber with one way valves; and a reservoir bag/pressure gauge/pressure relief/scavenger outlet arm.
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K Number
K060193Device Name
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
Manufacturer
OCEANIC MEDICAL PRODUCTS, INC.
Date Cleared
2006-04-10
(75 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
OCEANIC MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Magellan-2200 Model-2 Anesthesia Machine is intended for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.
The Magellan-2200 Model-2 Anesthesia Machine in indicated for use with spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.
Device Description
The Magellan-2200 Model-2 consists of the following components:
Gas Manifold with Safety Connections
Low Pressure Oxygen Alarm
Oxygen and Air Pressure Gauges
Oxygen Auxiliary Flow Selector
Oxygen and Air Flowmeters
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K Number
K010613Device Name
MAGELLAN-2200, MODEL 1
Manufacturer
OCEANIC MEDICAL PRODUCTS, INC.
Date Cleared
2001-10-12
(225 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
OCEANIC MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002951Device Name
MAGELLAN VENTILATOR
Manufacturer
OCEANIC MEDICAL PRODUCTS, INC.
Date Cleared
2000-12-08
(78 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
OCEANIC MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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