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FDA 510(k)

Applanation tonometer AT-2

K-Number: K182491 · 2018-12-10

ApplicantTakagi Seiko Co., Ltd.
Decision Date2018-12-10
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Applanation tonometer AT-2 is a medical device manufactured by Takagi Seiko Co., Ltd.. It received FDA 510(k) clearance on 2018-12-10 under approval number K182491. 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-2?

Applanation tonometer AT-2 is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Takagi Seiko Co., Ltd.. The 510(k) number is K182491.

When was Applanation tonometer AT-2 approved by the FDA?

Applanation tonometer AT-2 received FDA 510(k) clearance on 2018-12-10, under approval number K182491.

What company makes Applanation tonometer AT-2?

Applanation tonometer AT-2 is manufactured by Takagi Seiko Co., Ltd..

What is the FDA product code for Applanation tonometer AT-2?

The FDA product code for Applanation tonometer AT-2 is HKY.

Related Clinical Trials

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Other Devices by Takagi Seiko Co., Ltd.

K152535Z5 Slit lamp microscope, Z2 Slit lamp microscope K172728Applanation tonometer AT-1 K162636Marco Ultra M3, Marco Ultra M4

Related Devices (Code: HKY)

K153694Icare ic100Icare Finland OY K142263Applanation TonometerShanghai Mediworks Precision Instruments Co. , Ltd. K151491Falck Medical Multifunction Tonometer, FAT1Falck Medical, Inc. K172728Applanation tonometer AT-1Takagi Seiko Co., Ltd. K163343Icare HOME tonometerIcare Finland OY K180839AT 030Carl Zeiss Meditec, AG

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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