Device Name
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVERManufacturer
Date Cleared
1996-07-03
(19 days)
Product Code
Regulation Number
880.5270Type
TraditionalPanel
General HospitalAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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§ 880.5270 Neonatal eye pad.
(a)
Identification. A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.(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 § 880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.