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510(k) Data Aggregation
K Number
K212945Device Name
Sterile Disposable Temperature Probe
Manufacturer
Date Cleared
2022-03-01
(167 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Envisen Industry Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
- Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
- Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
Device Description
Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable which is also included in the submission as an accessory. These probes have a skin or core contact with a patient.
These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901.
Products are packed individually into a paper pouch in sterile condition.
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