RDP-2000

System, X-ray, Fluoroscopic, Image-intensified

MACHLETT LABORATORIES, INC.

The following data is part of a premarket notification filed by Machlett Laboratories, Inc. with the FDA for Rdp-2000.

Pre-market Notification Details

Device IDK813158
510k NumberK813158
Device Name:RDP-2000
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant MACHLETT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-16
Decision Date1982-01-19

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