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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 the device name listed in this FDA 510(k) record. The listed applicant is Innomed Healthscience, Inc.. It received FDA 510(k) clearance on 2018-08-16 under 510(k) 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. The listed applicant is Innomed Healthscience, Inc.. The 510(k) number is K180619.

When did Bongo receive FDA 510(k) clearance?

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

Who is the listed applicant for Bongo?

The FDA 510(k) record lists Innomed Healthscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bongo?

The FDA product code for Bongo is OHP.

Related Devices (Code: OHP)

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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