Fitbit, LLC
Body Temperature Software (BTS)
SKU DEN230050UPC QZA
In Stock
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IIFDA 510(k) Cleared (DEN230050)
1
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Fitbit, LLC
Free shipping on orders over $99 · 30-day returns
Body Temperature Software (BTS) is an FDA 510(k)-cleared medical device (DEN230050) manufactured by Fitbit, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2023. Regulation: 8.
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