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FDA 510(k)

Bongo

K-Number: K180619 · 2018-08-16

ApplicantInnomed Healthscience, Inc.
Decision Date2018-08-16
Product CodeOHP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bongo is a medical device manufactured by Innomed Healthscience, Inc.. It received FDA 510(k) clearance on 2018-08-16 under approval number K180619. The device is classified under product code OHP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bongo?

Bongo is a medical device that received FDA 510(k) clearance on 2018-08-16. It is manufactured by Innomed Healthscience, Inc.. The 510(k) number is K180619.

When was Bongo approved by the FDA?

Bongo received FDA 510(k) clearance on 2018-08-16, under approval number K180619.

What company makes Bongo?

Bongo is manufactured by Innomed Healthscience, Inc..

What is the FDA product code for Bongo?

The FDA product code for Bongo is OHP.

Related Devices (Code: OHP)

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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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