AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD

Accelerator, Linear, Medical

AKTINA MEDICAL PHYSICS CORP.

The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medical Physics Corporation Tilt Board.

Pre-market Notification Details

Device IDK991546
510k NumberK991546
Device Name:AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
ClassificationAccelerator, Linear, Medical
Applicant AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers,  NY  10920
ContactJoan Zacharopoulos
CorrespondentJoan Zacharopoulos
AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers,  NY  10920
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-03
Decision Date1999-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B365702000 K991546 000
B365538970 K991546 000
B365538020 K991546 000
B365526340 K991546 000
B365114500 K991546 000
B365114350 K991546 000
B365113800 K991546 000
B365113300 K991546 000
B365113250 K991546 000
B365112330 K991546 000
B365112300 K991546 000
B365542260 K991546 000
B365560530 K991546 000
B365605800 K991546 000
B365605600 K991546 000
B365605000 K991546 000
B365602800 K991546 000
B36511231S0 K991546 000
B365112310 K991546 000
B365112290 K991546 000
B365608120 K991546 000
B365701000 K991546 000
B365561100 K991546 000
B365112250 K991546 000

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