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FDA 510(k)

Marco Ultra M3, Marco Ultra M4

K-Number: K162636 · 2017-04-14

ApplicantTakagi Seiko Co., Ltd.
Decision Date2017-04-14
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Marco Ultra M3, Marco Ultra M4 is the device name listed in this FDA 510(k) record. The listed applicant is Takagi Seiko Co., Ltd.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K162636. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Marco Ultra M3, Marco Ultra M4?

Marco Ultra M3, Marco Ultra M4 is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Takagi Seiko Co., Ltd.. The 510(k) number is K162636.

When did Marco Ultra M3, Marco Ultra M4 receive FDA 510(k) clearance?

Marco Ultra M3, Marco Ultra M4 received FDA 510(k) clearance on 2017-04-14, under 510(k) number K162636.

Who is the listed applicant for Marco Ultra M3, Marco Ultra M4?

The FDA 510(k) record lists Takagi Seiko Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Marco Ultra M3, Marco Ultra M4?

The FDA product code for Marco Ultra M3, Marco Ultra M4 is HJO.

Other records listing Takagi Seiko Co., Ltd. as applicant

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Official Source

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