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Found 15 results
510(k) Data Aggregation
K Number
K220533Device Name
Endoscopy Oxygen Mask
Manufacturer
Engineered Medical Systems Inc.
Date Cleared
2022-11-16
(265 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Engineered Medical Systems Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endoscopy Oxygen Mask is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.
Device Description
The Endoscopy Oxygen Mask is a multi-port mask that serves several functions: A standard oxygen mask for when a patient requires supplemental oxygen; Sampling of exhaled gases for monitoring, typically end-tidal CO2; Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.
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K Number
K062104Device Name
TALKING TRACH
Manufacturer
ENGINEERED MEDICAL SYSTEMS, INC.
Date Cleared
2007-04-20
(270 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients. For adult patients > 30 kg.
Device Description
The proposed EMS Talking Trach is a tracheostomy tube which allows patients who are ventilator dependent or spontaneously breathing to speak or phonate. It can be used with patients on ventilators while the cuff is "up" or inflated. It is offered in sizes from 4.0 to 10.0 mm with disposable standard and speaking inner cannula.
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K Number
K023683Device Name
MULTI-STRAP FULL FACE MASK
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2003-12-01
(395 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. Single patient, multi-use
Device Description
The EMS Multi-strap Full Face mask covers both the nose and mouth and includes a nonrebreathing / anti-asphyxia valve, which is activated under flow / pressure from a CPAP or bilevel ventilator. It is open to ambient air when the ventilator is not ON allowing the patient to breath ambient air. It has a quick release mask harness system. It is single patient, multi-use.
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K Number
K013728Device Name
TRACH VOX
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2002-07-30
(263 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.
For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air.
Device Description
The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:
- HME media for humidifying inhaled air
- Suction port
- Method for closing off exhalation to outside and divert the exhaled breathe around the tracheostomy tube and through the vocal cords for speech
- Connector for delivery of supplemental oxygen
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K Number
K013122Device Name
EMS ELECTROSTATIC FLITER AND HME COMBINATION
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2002-04-19
(212 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient. Model with tidal volumes ranging from 20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for adults. Use up to 24 hours.
Device Description
The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
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K Number
K013089Device Name
EMS HEPA FILTER AND HME COMBINATIONS
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2002-03-14
(178 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient
Device Description
The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.
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K Number
K013123Device Name
EMS PULMONARY FUNCTION TESTING FILTER
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2002-03-14
(176 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with pulmonary function testing. To filter air between the patient's exhaled air and the testing equipment. Single patient use.
Device Description
The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
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K Number
K003497Device Name
DISPOSABLE PRESSURE MONITOR
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2000-11-30
(17 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000215Device Name
SWIVEL ELBOW
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2000-05-26
(123 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000314Device Name
INCENTIVE SPIROMETER
Manufacturer
ENGINEERED MEDICAL SYSTEMS
Date Cleared
2000-04-12
(71 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
ENGINEERED MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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