NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES

Camera, Scintillation (gamma)

BIODAN MEDICAL SYSTEMS, LTD.

The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Nuclear Patient Sanning Tables, Various Types.

Pre-market Notification Details

Device IDK926083
510k NumberK926083
Device Name:NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES
ClassificationCamera, Scintillation (gamma)
Applicant BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley,  NY  11967
ContactClyde Schlein
CorrespondentClyde Schlein
BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley,  NY  11967
Product CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-01
Decision Date1993-02-12

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