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FDA 510(k)

COMP A-I-R

K-Number: K110860 · 2011-09-02

ApplicantOmron Healthcare, Inc.
Decision Date2011-09-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMP A-I-R is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2011-09-02 under 510(k) number K110860. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMP A-I-R?

COMP A-I-R is a medical device that received FDA 510(k) clearance on 2011-09-02. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K110860.

When did COMP A-I-R receive FDA 510(k) clearance?

COMP A-I-R received FDA 510(k) clearance on 2011-09-02, under 510(k) number K110860.

Who is the listed applicant for COMP A-I-R?

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

What is the FDA product code for COMP A-I-R?

The FDA product code for COMP A-I-R is CAF.

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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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