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510(k) Data Aggregation
K Number
K071977Device Name
TARRY MEDICAL TEMPERATURE PROBES
Manufacturer
Date Cleared
2008-05-23
(311 days)
Regulation Number
880.5400Why did this record match?
Applicant Name (Manufacturer) :
TARRY MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.
Device Description
The Tarry Medical Temperature Probes are intended to be used as replacement parts as various neonatal incubators including:
- Drager / Air Shields / Hill-Rom Isolette Incubators
- Drager / Air Shields / Hill-Rom Incubators
- GE / Ohmeda / Ohio IC and GC Care Plus
- GE / Ohmeda Panda Baby Warmers
- GE / Ohmeda Infant Warmer Systems
This 510(k) includes the following probes:
T-100 (skin temperature probe)
T-3000 (skin temperature probe)
T-20970 (skin temperature probe)
T-20980 (air temperature probe)
The temperature probes are for use with incubators and warmers in a hospital setting. The probes are reusable and reusable models. The probes were designed to meet OEM product specifications.
The temperature probes include thermistors and are used with disposable probe covers.
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