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FDA 510(k)

OMNI 5 TOTAL O2 DELIVERY SYSTEM

K-Number: K091028 · 2009-07-23

ApplicantRespironics, Inc.
Decision Date2009-07-23
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OMNI 5 TOTAL O2 DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2009-07-23 under 510(k) number K091028. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI 5 TOTAL O2 DELIVERY SYSTEM?

OMNI 5 TOTAL O2 DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-23. The listed applicant is Respironics, Inc.. The 510(k) number is K091028.

When did OMNI 5 TOTAL O2 DELIVERY SYSTEM receive FDA 510(k) clearance?

OMNI 5 TOTAL O2 DELIVERY SYSTEM received FDA 510(k) clearance on 2009-07-23, under 510(k) number K091028.

Who is the listed applicant for OMNI 5 TOTAL O2 DELIVERY SYSTEM?

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

What is the FDA product code for OMNI 5 TOTAL O2 DELIVERY SYSTEM?

The FDA product code for OMNI 5 TOTAL O2 DELIVERY SYSTEM is CAW.

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Related Devices (Code: CAW)

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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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