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FDA 510(k)

eCarbon IBDs

K-Number: K191537 · 2019-09-26

ApplicantBack 2 Basics Direct, LLC
Decision Date2019-09-26
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

eCarbon IBDs is a medical device manufactured by Back 2 Basics Direct, LLC. It received FDA 510(k) clearance on 2019-09-26 under approval number K191537. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eCarbon IBDs?

eCarbon IBDs is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by Back 2 Basics Direct, LLC. The 510(k) number is K191537.

When was eCarbon IBDs approved by the FDA?

eCarbon IBDs received FDA 510(k) clearance on 2019-09-26, under approval number K191537.

What company makes eCarbon IBDs?

eCarbon IBDs is manufactured by Back 2 Basics Direct, LLC.

What is the FDA product code for eCarbon IBDs?

The FDA product code for eCarbon IBDs is ODP.

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Official Source

View on FDA Database →

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

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