FDA 510(k)

Marco Ultra M3, Marco Ultra M4

K-Number: K162636 · 2017-04-14

Decision Date2017-04-14

Product CodeHJO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Marco Ultra M3, Marco Ultra M4 is a medical device manufactured by Takagi Seiko Co., Ltd.. It received FDA 510(k) clearance on 2017-04-14 under approval 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. It is manufactured by Takagi Seiko Co., Ltd.. The 510(k) number is K162636.

When was Marco Ultra M3, Marco Ultra M4 approved by the FDA?

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

What company makes Marco Ultra M3, Marco Ultra M4?

Marco Ultra M3, Marco Ultra M4 is manufactured by Takagi Seiko Co., Ltd..

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 Devices by Takagi Seiko Co., Ltd.

K152535Z5 Slit lamp microscope, Z2 Slit lamp microscope K172728Applanation tonometer AT-1 K182491Applanation tonometer AT-2

Related Devices (Code: HJO)

K161972Slit Lamp SL-D301Topcon Corporation K160327ALADDIN HW3.0Visia Imaging S.R.L. K153545Portable Slit LampShanghai Bolan Optical-Electric Co., Ltd. K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. K152429Slit Lamp MicroscopeShanghai Mediworks Precision Instruments Co. , Ltd. K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd.

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.