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K Number
K972136
Device Name
TV MONITOR (P12/17)
Manufacturer
PERKINS MFG. CO.
Date Cleared
1997-06-26

(20 days)

Product Code
IZI
Regulation Number
892.1600
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

TV Monitor Model P12/17 SCREEN (CRT)

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a TV Monitor Model P12/17. This letter is a regulatory document and does not contain information about acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.