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510(k) Data Aggregation
K Number
K081094Device Name
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
2008-06-20
(64 days)
Product Code
MEC
Regulation Number
880.6992Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment in a hot water bath at 160° - 170° F for 30 minutes.
Device Description
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are used for the cleaning and high-level disinfection of reusable and disposable breathing circuit parts used in Respiratory Therapy and Anesthesia. Pasteurization kills pathogenic vegetative bacteria and viruses by immersion in water at 160° - 170° F for 30 minutes. Full immersion pasteurization has been identified by the Centers for Disease Control as suitable for high-level disinfection of all parts not used subcutaneously.
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are identical systems with the exception of the heater capacity. The Pasteurmatic 3000 has three 3,000 watt heaters for a system capacity of 9,000 watts. The Pasteurmatic 3500 has three 5,000 watt heaters for a system capacity of 15,000 watts to allow more rapid heating of the water during the pasteurization cycle when used as a combined washerpasteurizer.
Both systems rotate stainless steel baskets of tubes and parts vertically in a stainless steel tank during both washing and pasteurizing. This forces water through the full length of the tubes and drives out all the air bubbles.
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K Number
K031149Device Name
OLYMPIC CFM 6000
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
2003-05-14
(34 days)
Product Code
OMA, OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympic CFM 6000 is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:
- to monitor the state of the brain -
- for determination of, and long-term monitoring of, the neurological status of a patients that may have suffered an hypoxic-ischemic event.
- for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
- to assist in the prediction of neurological outcome -
- to monitor and record frequency and intensity of seizures to assist in management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy ー and long-term outcome in infants who have suffered an hypoxic-ischemic event.
Device Description
The Olympic CFM 6000 consists of two main components: A Data Acquisition Module and a Main System module. The Data Acquisition Module is used to connect the patient electrode leads, amplify the signal, and perform the analog-to-digital conversion. The Main system accepts data from the amplifier. processes and stores the signal. and displays the CFM, impedance, and EEG traces and provides the user interface for control of the device.
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K Number
K020335Device Name
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
2002-06-18
(137 days)
Product Code
OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:
- to monitor the state of the brain .
- for determination of, and long-term monitoring of, the neurological status of patients that may have suffered an hypoxic-ischemic event.
- for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
- to assist in the prediction of neurological outcome -
- to monitor and record frequency and intensity of seizures to assist in management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy and long-term outcome in infants who have suffered an hypoxic-ischemic event.
Device Description
The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module that produces three outputs that may be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.
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K Number
K001056Device Name
OLYMPIC WARM-UP
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
2000-09-29
(179 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983229Device Name
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
1999-03-23
(189 days)
Product Code
OMA, OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
Device Description
The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module which produces three outputs which mav be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.
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K Number
K971601Device Name
OLYMPIC BILI-BASSINET
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
1997-09-24
(146 days)
Product Code
LBI, DAT
Regulation Number
880.5700Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the treatment of Neonatal Hyperbilirubinemia.
Device Description
The Olympic Bili-Bassinet has three phototherapy fixtures built into a bassinet.
The two identical overhead fixtures swing and lock in their up position. They are mounted on counter-balanced arms. Thier storage position is recessed into the sides of the bassinet.
The phototherapy pad is a pad/mattress, which is transparent to light. Unlike a fiberoptic pad, which used plastic optical fibers within the pad to transmit the light from the remote light box, the Bili-Bassinet light box is below the pad/mattress and shines through the pad.
All fixtures use conventional blue (type "B") fluorescent phototherapy lamps. "Daylight" and high-intensity (type BB) fluorescent lights are available for use in the overhead fixtures.
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K Number
K972193Device Name
OLYMPIX MINI-PASTEURMATIC (58210)
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
1997-09-05
(87 days)
Product Code
LDS
Regulation Number
880.6991Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers.
Device Description
The Olympic Mini-Pasteurmatic is a small, compact machine. which makes use of pasteurization to achieve high-level disinfection of respiratory therapy and anesthesia breathing circuit parts. After hand washing, the parts are placed in the drum shaped "basket." The basket is submerged in hot water and rotated vertically. This vertical rotation flushes water through tubes and other hollow parts, allowing air to escape and improving water contact with all surfaces of the parts. The Mini-Pasteurmatic is filled with water, which is heated to pasteurizing temperature by internal heaters.
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K Number
K971117Device Name
WARMETTE
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
1997-08-22
(148 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For WAZMING BLANKETS/LINEN o R or Solutions SOLUTIONS MUST 136 . 197 EXTERNAL ાર્ટ હ ONLy ,
Device Description
All Olympic Warmettes are essentially double walled, insulated cabinets with transparent doors. The Warmettes normally remain on continuously. The temperature is user selectable. The Model 10 uses a resistance element heater encapsuled in a high temperature r lie Model 10 uses a roclocanos element of the interior. Due to the small size, forced air circulation is not needed. The Models 30, 31 and 40 make use of a fan to force recirculating air past The Models 50, of and 10 make see above the main chamber) and then into the resistence heating bientified (roothe heaters via an air duct built into the left wall. The Models 31 and 40 differ from the Model 30 in two respects: · The selectable maximum temperature is higher. - · The delivery duct/plenum inside the right wall is more efficient, allowing the Models 31 and 40 to operate at the higher temperatures.
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K Number
K955357Device Name
OLYMPIC SMART SCALE MODEL 50/50RA
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
1996-01-30
(99 days)
Product Code
FRW
Regulation Number
880.2720Why did this record match?
Applicant Name (Manufacturer) :
OLYMPIC MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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