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FDA 510(k)

MC-245, MC-246, MC-247, MC-341, MC-343, MC-344

K-Number: K091676 · 2009-09-01

ApplicantOmron Healthcare, Inc.
Decision Date2009-09-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 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 2009-09-01 under 510(k) number K091676. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MC-245, MC-246, MC-247, MC-341, MC-343, MC-344?

MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 is a medical device that received FDA 510(k) clearance on 2009-09-01. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K091676.

When did MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 receive FDA 510(k) clearance?

MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 received FDA 510(k) clearance on 2009-09-01, under 510(k) number K091676.

Who is the listed applicant for MC-245, MC-246, MC-247, MC-341, MC-343, MC-344?

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 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344?

The FDA product code for MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 is FLL.

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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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