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510(k) FDA Premarket Notification K241157

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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
08800016905182 K241157 000
08800016903171 K241157 000
08800016903423 K241157 000
08800016903447 K241157 000
08800016903454 K241157 000
08800016904246 K241157 000
08800016904253 K241157 000
08800016904291 K241157 000
08800016905045 K241157 000
08800016905052 K241157 000
08800016905069 K241157 000
08800016905076 K241157 000
08800016905083 K241157 000
08800016905090 K241157 000
08800016905106 K241157 000
08800016905175 K241157 000
08800016903140 K241157 000

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