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Found 4 results
510(k) Data Aggregation
K Number
K003876Device Name
US SENSOR #CG-930P; TOCO SENSOR CG-940P
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2001-07-09
(206 days)
Product Code
HEL
Regulation Number
884.2660Why did this record match?
Product Code :
HEL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Product Code :
HEL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982651Device Name
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
Manufacturer
COROMETRICS MEDICAL SYSTEMS, INC.
Date Cleared
1998-12-11
(134 days)
Product Code
HEL
Regulation Number
884.2660Why did this record match?
Product Code :
HEL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water environment.
Device Description
The Model 5700 and 2264 Series Non-Invasive Watertight Transducers are intended as accessories to Corometrics' Fetal and Fetal/Maternal Monitors. The Model 5700 Series Transducer provides for the detection of fetal heart rate and the Model 2264 Series Transducer provides for the detection of uterine activity.
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K Number
K971240Device Name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1997-06-06
(65 days)
Product Code
HEL
Regulation Number
884.2660Why did this record match?
Product Code :
HEL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Replaces R&D Batteries part Number 5164 (K933687 and K951403) which are used in Sonicaid fetal heart monitors D100RE, D102R PN 1000-0006 K#873673.
Device Description
MOOlo Replacement Battery
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