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FDA 510(k)

Applanation tonometer AT-1

K-Number: K172728 · 2017-10-17

ApplicantTakagi Seiko Co., Ltd.
Decision Date2017-10-17
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Applanation tonometer AT-1 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 2017-10-17 under 510(k) number K172728. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Applanation tonometer AT-1?

Applanation tonometer AT-1 is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Takagi Seiko Co., Ltd.. The 510(k) number is K172728.

When did Applanation tonometer AT-1 receive FDA 510(k) clearance?

Applanation tonometer AT-1 received FDA 510(k) clearance on 2017-10-17, under 510(k) number K172728.

Who is the listed applicant for Applanation tonometer AT-1?

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 Applanation tonometer AT-1?

The FDA product code for Applanation tonometer AT-1 is HKY.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182491Applanation tonometer AT-2K162636Marco Ultra M3, Marco Ultra M4K152535Z5 Slit lamp microscope, Z2 Slit lamp microscope

Related Devices (Code: HKY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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