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Data / Medical devices / Japan / Takagi Seiko Co., Ltd.

Takagi Seiko Co., Ltd.: FDA-registered device maker in NAKANO-SHI Nagano, Japan, 5 510(k) clearances

Takagi Seiko Co., Ltd. is registered with the FDA (registration 9710516) in NAKANO-SHI Nagano, Japan. It lists 12 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 10, 2018. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Takagi Seiko Co., Ltd.
FDA registration number
9710516
FEI number
3001802794
Address
330-2 Iwafune, NAKANO-SHI Nagano, Japan, 383-8585
Owner or operator
TAKAGI SEIKO CO., LTD. (9025906)
Roles
Exporter to the US, Manufacturer
First device listed
July 25, 2001
Registered through
2027
Brand names listed
APPLANATION TONOMETER AT-1, APPLANATION TONOMETER AT-2, CHART PROJECTOR CP-40, Ellex 30XL SLITLAMP, MARCO AT-8 APPLANATION TONOMETER, MARCO AT-9 APPLANATION TONOMETER, MARCO BRAVO CHAIR, MARCO BRAVO STAND and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Exporter to the US, Manufactureraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered, ExemptPUE2Exporter to the US, Manufactureraccessdata.fda.gov
Chair, Ophthalmic, Ac-PoweredHME1Exporter to the US, Manufactureraccessdata.fda.gov
Chair, Ophthalmic, ManualHMD1Exporter to the US, Manufactureraccessdata.fda.gov
Frame, Trial, OphthalmicHPA1Exporter to the US, Manufactureraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Exporter to the US, Manufactureraccessdata.fda.gov
Perimeter, Ac-PoweredHOO1Exporter to the US, Manufactureraccessdata.fda.gov
Projector, OphthalmicHOS1Exporter to the US, Manufactureraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Exporter to the US, Manufactureraccessdata.fda.gov
Stand, Instrument, Ac-Powered, OphthalmicHMF1Exporter to the US, Manufactureraccessdata.fda.gov
Table, Instrument, Powered, OphthalmicHRJ1Exporter to the US, Manufactureraccessdata.fda.gov
Tonometer, ManualHKY2Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 10, 2018K182491Applanation tonometer AT-2HKYSubstantially EquivalentTakagi Seiko Co., Ltd.accessdata.fda.gov
October 17, 2017K172728Applanation tonometer AT-1HKYSubstantially EquivalentTakagi Seiko Co., Ltd.accessdata.fda.gov
April 14, 2017K162636Marco Ultra M3, Marco Ultra M4HJOSubstantially EquivalentTakagi Seiko Co., Ltd.accessdata.fda.gov
May 26, 2016K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeHJOSubstantially EquivalentTakagi Seiko Co., Ltd.accessdata.fda.gov
March 13, 2007K063352ELLEX SLIT LAMP, MODEL 30XLHJOSubstantially EquivalentTakagi Seiko Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated December 10, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.