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Found 18 results
510(k) Data Aggregation
K Number
K212922Device Name
Nitrile Examination Gloves
Manufacturer
HSK Medical Apparatus Foshan China Co. LTD
Date Cleared
2021-12-10
(87 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HSK Medical Apparatus Foshan China Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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K Number
K031860Device Name
SK MED ME202 MONITORING MIXER
Manufacturer
SK MED
Date Cleared
2004-01-21
(219 days)
Product Code
BZR, CCL
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
SK MED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmcter (1 to 12 I.PM). The device is a prescription device and is intended for use within the hospital or institutional environment.
Device Description
SK Med M202 Mixer
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K Number
K031707Device Name
SK MED M201 PLUS MIXER
Manufacturer
SK MED
Date Cleared
2003-08-01
(60 days)
Product Code
BZR, CCL
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
SK MED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M201Plus Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.
Device Description
Not Found
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K Number
K022864Device Name
SK MED M201 MIXER
Manufacturer
SK MED
Date Cleared
2003-04-11
(226 days)
Product Code
BZR, CCL
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
SK MED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M201 Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.
Device Description
Not Found
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K Number
K011071Device Name
PARADIGM QUICK-SET INFUSION SET
Manufacturer
MAERSK MEDICAL A/S
Date Cleared
2001-06-07
(59 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MAERSK MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K004028Device Name
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
Manufacturer
MAERSK MEDICAL, LTD.
Date Cleared
2001-03-27
(90 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MAERSK MEDICAL, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002138Device Name
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
Manufacturer
MAERSK MEDICAL A/S
Date Cleared
2000-08-29
(43 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MAERSK MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990110Device Name
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
Manufacturer
MAERSK MEDICAL A/S
Date Cleared
1999-12-06
(327 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
MAERSK MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ECG monitoring electrodes for short-term use (< 24 hours) in adults (Model 4110) and infants (Model 4140).
Device Description
Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
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K Number
K990111Device Name
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
Manufacturer
MAERSK MEDICAL A/S
Date Cleared
1999-12-06
(327 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
MAERSK MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Short-term (< 24 hrs) ECG monitoring of infants in operating room and emergency situations (Model 4570); short-term (< 24 hrs) ECG monitoring of infants and neonates in operating room and emergency situations (Model 4520); short-term (< 24 hrs) ECG monitoring of adults and infants under anesthesia (Model 4535).
Device Description
Pregelled electrodes are of Aq/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
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K Number
K990112Device Name
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
Manufacturer
MAERSK MEDICAL A/S
Date Cleared
1999-12-06
(327 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
MAERSK MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ECG monitoring electrodes for short-term use (<24 hours) in adults (Model 4060) and infants (Model 4610).
Device Description
Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 55 mm in diameter or rectanqular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
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