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K Number
K981093
Device Name
WESCO BLANKET
Manufacturer
WESCO, INC.
Date Cleared
2000-03-28

(733 days)

Product Code
DWJ
Regulation Number
870.5900
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For Patient Temperature Management

Device Description

Wesco Blanket

AI/ML Overview

I am sorry, but the provided text is a set of FDA correspondence letters regarding a 510(k) clearance for a "Wesco Blanket," and an "Indications for Use" statement.

This document does not contain information about:

  • Acceptance criteria for device performance
  • A study proving device meets acceptance criteria
  • Reported device performance statistics
  • Sample sizes for test or training sets
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies or effect sizes
  • Standalone algorithm performance
  • Type of ground truth used

Therefore, I cannot fulfill your request for these specific details. The document primarily confirms the substantial equivalence of the Wesco Blanket to a predicate device for patient temperature management, allowing it to be legally marketed.

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).