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510(k) FDA Premarket Notification K240560

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The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

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Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800070233405 K240560 000
08800070218693 K240560 000
08800070218709 K240560 000
08800070218754 K240560 000
08800070218761 K240560 000
08800070218778 K240560 000
08800070218792 K240560 000
08800070218839 K240560 000
08800070218846 K240560 000
08800070218686 K240560 000
08800070218679 K240560 000
08800070201534 K240560 000
08800070201602 K240560 000
08800070202043 K240560 000
08800070202050 K240560 000
08800070202128 K240560 000
08800070218617 K240560 000
08800070218624 K240560 000
08800070218631 K240560 000
08800070218853 K240560 000
08800070218860 K240560 000
08800070229491 K240560 000
08800070229569 K240560 000
08800070233313 K240560 000
08800070233320 K240560 000
08800070233337 K240560 000
08800070233344 K240560 000
08800070233382 K240560 000
08800070233399 K240560 000
08800070229484 K240560 000
08800070228326 K240560 000
08800070218938 K240560 000
08800070218945 K240560 000
08800070218952 K240560 000
08800070218969 K240560 000
08800070218983 K240560 000
08800070218990 K240560 000
08800070228241 K240560 000
08800070228258 K240560 000
08800070201527 K240560 000

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