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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
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.