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510(k) Data Aggregation
Device Name
READY-HEAT BLANKETManufacturer
Date Cleared
2004-09-17
(39 days)
Product Code
Regulation Number
880.6060Type
TraditionalPanel
General HospitalAge Range
All
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
To provide warm relief
Device Description
Ready Heat™ blanket
AI/ML Overview
This document is a 510(k) premarket notification letter from the FDA regarding the "Ready Heat™ Blanket." It primarily addresses regulatory approval and does not contain specific information about acceptance criteria or a study proving the device meets them.
Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence to predicate devices, not performance testing details.
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