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K Number
K023283
Device Name
1075LD HUSH-SLUSH
Manufacturer
O.R. SOLUTIONS, INC.
Date Cleared
2002-11-13

(43 days)

Product Code
LHC
Regulation Number
890.5950
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ORS-1075LD is designed to cool surgical irrigation solutions and/or create slush.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "1075LD Hush-Slush®," primarily addressing its substantial equivalence to predicate devices and outlining regulatory obligations.

Therefore, I cannot provide the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth establishment.

§ 890.5950 Powered heating unit.

(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.