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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 the device name listed in this FDA 510(k) record. The listed applicant is 11 Health Technologies Limited. It received FDA 510(k) clearance on 2018-11-16 under 510(k) 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. The listed applicant is 11 Health Technologies Limited. The 510(k) number is K181643.

When did SmartBag (SmartPouch) receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartBag (SmartPouch)?

The FDA 510(k) record lists 11 Health Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: EXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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