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FDA 510(k)

MODEL PM3030

K-Number: K110068 · 2011-12-08

ApplicantOmron Healthcare, Inc.
Decision Date2011-12-08
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL PM3030 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 2011-12-08 under 510(k) number K110068. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL PM3030?

MODEL PM3030 is a medical device that received FDA 510(k) clearance on 2011-12-08. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K110068.

When did MODEL PM3030 receive FDA 510(k) clearance?

MODEL PM3030 received FDA 510(k) clearance on 2011-12-08, under 510(k) number K110068.

Who is the listed applicant for MODEL PM3030?

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 MODEL PM3030?

The FDA product code for MODEL PM3030 is NUH.

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Related Devices (Code: NUH)

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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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