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FDA 510(k)

SmartBag (SmartPouch)

K-Number: K181643 · 2018-11-16

Applicant11 Health Technologies Limited
Decision Date2018-11-16
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SmartBag (SmartPouch) is a medical device manufactured by 11 Health Technologies Limited. It received FDA 510(k) clearance on 2018-11-16 under approval number K181643. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartBag (SmartPouch)?

SmartBag (SmartPouch) is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by 11 Health Technologies Limited. The 510(k) number is K181643.

When was SmartBag (SmartPouch) approved by the FDA?

SmartBag (SmartPouch) received FDA 510(k) clearance on 2018-11-16, under approval number K181643.

What company makes SmartBag (SmartPouch)?

SmartBag (SmartPouch) is manufactured by 11 Health Technologies Limited.

What is the FDA product code for SmartBag (SmartPouch)?

The FDA product code for SmartBag (SmartPouch) is EXB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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