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510(k) Data Aggregation
K Number
K063863Device Name
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
Manufacturer
ADVANTAGE MEDICAL CABLES, INC.
Date Cleared
2007-03-20
(82 days)
Product Code
DXQ
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE MEDICAL CABLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AMC replacement non-invasive blood pressure cuffs, interface hoses and adapters are accessories for noninvasive blood pressure systems with manual or automated noninvasive sphygmomanometers. The cuffs, interface hoses and adapters are supplied non-sterile and may be reused. The NIBP Cuffs and interface cables are supplied in adult, pediatric, infant and neonatal sizes. The cuffs, interface hoses and adapters are not designed, sold or intended for use except as indicated.
Device Description
The Advantage Cuff, NIBP Hose and Adapters are accessories for noninvasive blood pressure systems. Cuff: The cuff is comprised of an air tight bladder enclosed in an inelastic sleeve with one or two tubes and the appropriate connectors for the type device required. The Advantage Cuffs come in a range of sizes, each marked with the appropriate limb circumference for which the cuff is intended. Hose: The hose is comprised of single or dual tubing, in various lengths as required by the customer or application, with the appropriate connectors attached to each end of the tubing. Adapters: The adapters are comprised of short pieces of tubing in a "Y" configuration primarily to adapt a single tube cuff to a dual tube hose or a dual tube cuff to a single tube hose as required by the customer.
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K Number
K010920Device Name
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
Manufacturer
MEDICAL CABLES, INC.
Date Cleared
2001-06-22
(87 days)
Product Code
HEL
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL CABLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002781Device Name
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
Manufacturer
MEDICAL CABLES, INC.
Date Cleared
2000-11-29
(84 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL CABLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K973970Device Name
SPO2 FINGER PROBES
Manufacturer
MEDICAL CABLES, INC.
Date Cleared
1998-10-06
(354 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL CABLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The compatible Medical Cables, Inc. SpO2 Finger Probe has the same intended use as the predicate probes, i.e. recommended for use in short term continuous noninvasive SpO2 saturation and pulse rate monitoring on patients weighing greater than 40kg. The intended environment of use of the Medical Cables SpO2 Finger Probe is the same as the predicate probe, i.e. in a medical or clinical environment under the direction of a physician.
Device Description
SpO2 Finger Probe Models P856RA, P861RA, P862RA, P867RA, and P876RA
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