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FDA 510(k)

OmniCap

K-Number: K171235 · 2018-01-04

ApplicantRespirion, Inc.
Decision Date2018-01-04
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OmniCap is a medical device manufactured by Respirion, Inc.. It received FDA 510(k) clearance on 2018-01-04 under approval number K171235. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniCap?

OmniCap is a medical device that received FDA 510(k) clearance on 2018-01-04. It is manufactured by Respirion, Inc.. The 510(k) number is K171235.

When was OmniCap approved by the FDA?

OmniCap received FDA 510(k) clearance on 2018-01-04, under approval number K171235.

What company makes OmniCap?

OmniCap is manufactured by Respirion, Inc..

What is the FDA product code for OmniCap?

The FDA product code for OmniCap is CCK.

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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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