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K Number
K992258
Device Name
HOT SHOT FLUID WARMER IV FLUIDS
Manufacturer
INFRA-MED TECHNOLOGIES, INC.
Date Cleared
2000-01-12

(190 days)

Product Code
LDQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Warm intravenous fluids.

Device Description

HOT SHOT™ FLUID WARMER IV FLUIDS

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Hot Shot™ Fluid Warmer IV Fluids." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

N/A