GERATHERM MERCUIRY FREE CLINICAL THERMOMETER

• K Number: K960224
• Device Name: GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
• Manufacturer: RG ENT., INC.
• Date Cleared: 1996-03-25 ( 68 days)
• Product Code: FLK
• Regulation Number: 880.2920
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 880.2920 Clinical mercury thermometer.

(a)
Identification. A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.