Search Results
Found 1 results
510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
COROMETRICS MEDICAL SYSTEMS, INC.
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.
Ask a Question
Page 1 of 1