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K Number
K003305
Device Name
PEDIATRIC INGESTASCAN
Manufacturer
ADAMS ELECTRONICS, INC.
Date Cleared
2000-12-22

(63 days)

Product Code
HPM
Regulation Number
886.4400
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.4400 Electronic metal locator.

(a)
Identification. An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.