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510(k) FDA Premarket Notification K232611

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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
00190837169107 K232611 000
00190837169251 K232611 000
00190837169244 K232611 000
00190837169237 K232611 000
00190837169220 K232611 000
00190837169213 K232611 000
00190837169206 K232611 000
00190837169190 K232611 000
00190837169183 K232611 000
00190837097172 K232611 000
00190837097165 K232611 000
00190837097158 K232611 000
00190837097141 K232611 000
00190837169121 K232611 000
00190837169138 K232611 000
00190837207298 K232611 000
00190837203443 K232611 000
00190837169114 K232611 000
00190837169091 K232611 000
00190837169084 K232611 000
00190837097189 K232611 000
00190837207335 K232611 000
00190837207328 K232611 000
00190837207311 K232611 000
00190837207304 K232611 000
00190837169152 K232611 000
00190837169145 K232611 000
00190837097134 K232611 000

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