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510(k) Data Aggregation
K Number
K052335Device Name
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
Manufacturer
ACCUTRON, INC.
Date Cleared
2005-11-23
(89 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
ACCUTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.
Device Description
The Accutron Digital Ultra Analgesia Gas Machine precisely meters oxygen and nitrous oxide medical gases for conscious sedation of patients in dental offices and hospitals. With the device, the attending physician or dentist is able to set both the percentage of nitrous oxide and the total flow to a desired level of sedation and flow. The Digital Ultra Analgesia Gas Machine has been designed with built in safety features that prevent the level of oxygen gas from falling below 30% of total flow, mechanical features that prevent the mix-up of gases, and fail-safe features to prevent the flow of nitrous oxide in the absence of oxygen gas.
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K Number
K033503Device Name
RFS VACUUM GAUGE SCAVENGING CIRCUIT
Manufacturer
ACCUTRON, INC.
Date Cleared
2004-03-12
(128 days)
Product Code
CBN
Regulation Number
868.5430Why did this record match?
Applicant Name (Manufacturer) :
ACCUTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases, for the removal from the treatment location of gases expired by the patient, and removal from the treatment location any excess gases delivered to a patient.
Device Description
The RFS Vacuum Gauge Scavenging Circuit is designed for the removal of patient expired and excess gases during nitrous oxide / oxygen sedation procedures. For proper operation, the scavenging circuit must be connected to a vacuum pump capable of providing at least 45 LPM of scavenging on an operating vacuum pressure of 8 in Hg. The vacuum pump should vent exhaust gases to the outside of the building, away from fresh air intakes, windows, or walkways.
The scavenging circuit consists of the scavenging hub, which connects to a nasal hood, exhaust tubing and connectors; and the RFS Vacuum Gauge. The nasal hood fits over the patient's nasal cavity, which serves to deliver medical gases to the patient and which allows removal of expired, excess, and unused medical gases from the nasal hood and surrounding areas.
This device measures pressure, not flow. Setting the float ball at the yellow indicator level This device measures pressure. This will result in the NIOSH recommended 45 LPM provided the mask is correctly attached, and there are no kinks or obstructions in the flow path.
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K Number
K992421Device Name
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
Manufacturer
ACCUTRON, INC.
Date Cleared
1999-10-27
(98 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
ACCUTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Accessory device for use with nitrous oxide / oxygen sedation systems to monitor the medical gas system for a low oxygen pressure condition (less than 40 ps), and activate an audio alarm when this condition exists.
Device Description
The Guardian™ Low Pressure Monitor Model 34076 will consist of the following major sub-components:
- . Circuit board with battery holder and battery
- . Pressure switch
- Manifold and medical gas fittings (DISS)
- . Protective cover
The intended major functional characteristics of the device are:
- . Audibly indicate proper initialization upon insertion of the battery (i.e. power up)
- Audibly indicate low tank pressure
- . Audibly indicate low remaining battery life, as determined by battery voltage
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K Number
K965239Device Name
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)
Manufacturer
ACCUTRON, INC.
Date Cleared
1997-03-28
(87 days)
Product Code
CBN
Regulation Number
868.5430Why did this record match?
Applicant Name (Manufacturer) :
ACCUTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970046Device Name
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
Manufacturer
ACCUTRON, INC.
Date Cleared
1997-03-28
(81 days)
Product Code
KHA
Regulation Number
868.5590Why did this record match?
Applicant Name (Manufacturer) :
ACCUTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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