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FDA 510(k)

NIDEK RT-1200S (MARCO TRS-1200)

K-Number: K901513 · 1990-06-08

ApplicantNidek, Inc.
Decision Date1990-06-08
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK RT-1200S (MARCO TRS-1200) is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1990-06-08 under 510(k) number K901513. The device is classified under product code HKO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK RT-1200S (MARCO TRS-1200)?

NIDEK RT-1200S (MARCO TRS-1200) is a medical device that received FDA 510(k) clearance on 1990-06-08. The listed applicant is Nidek, Inc.. The 510(k) number is K901513.

When did NIDEK RT-1200S (MARCO TRS-1200) receive FDA 510(k) clearance?

NIDEK RT-1200S (MARCO TRS-1200) received FDA 510(k) clearance on 1990-06-08, under 510(k) number K901513.

Who is the listed applicant for NIDEK RT-1200S (MARCO TRS-1200)?

The FDA 510(k) record lists Nidek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIDEK RT-1200S (MARCO TRS-1200)?

The FDA product code for NIDEK RT-1200S (MARCO TRS-1200) is HKO.

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Other records listing Nidek, Inc. 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.

K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

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Related Devices (Code: HKO)

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.

K031831TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMTopcon Medical Systems, Inc.K000327WAVESCAN WAVEFRONT SYSTEM MODEL HS 1Visx, IncorporatedK951179DIGITAL RETINOSCOPIC PHOTOMETERKudi Kalu, Inc.K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USAK942242AUTO REF-KERATOMETER, RK-3Cannon U.S.A., Inc.K940516AUTO REFF-30Canon, Inc.

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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