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FDA 510(k)

Z5 Slit lamp microscope, Z2 Slit lamp microscope

K-Number: K152535 · 2016-05-26

ApplicantTakagi Seiko Co., Ltd.
Decision Date2016-05-26
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Z5 Slit lamp microscope, Z2 Slit lamp microscope 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 2016-05-26 under 510(k) number K152535. 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 Z5 Slit lamp microscope, Z2 Slit lamp microscope?

Z5 Slit lamp microscope, Z2 Slit lamp microscope is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Takagi Seiko Co., Ltd.. The 510(k) number is K152535.

When did Z5 Slit lamp microscope, Z2 Slit lamp microscope receive FDA 510(k) clearance?

Z5 Slit lamp microscope, Z2 Slit lamp microscope received FDA 510(k) clearance on 2016-05-26, under 510(k) number K152535.

Who is the listed applicant for Z5 Slit lamp microscope, Z2 Slit lamp microscope?

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 Z5 Slit lamp microscope, Z2 Slit lamp microscope?

The FDA product code for Z5 Slit lamp microscope, Z2 Slit lamp microscope is HJO.

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

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Official Source

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