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FDA 510(k)

SATURN 9000

K-Number: K063710 · 2007-07-16

ApplicantNew Medical Co., Ltd.
Decision Date2007-07-16
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SATURN 9000 is the device name listed in this FDA 510(k) record. The listed applicant is New Medical Co., Ltd.. It received FDA 510(k) clearance on 2007-07-16 under 510(k) number K063710. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATURN 9000?

SATURN 9000 is a medical device that received FDA 510(k) clearance on 2007-07-16. The listed applicant is New Medical Co., Ltd.. The 510(k) number is K063710.

When did SATURN 9000 receive FDA 510(k) clearance?

SATURN 9000 received FDA 510(k) clearance on 2007-07-16, under 510(k) number K063710.

Who is the listed applicant for SATURN 9000?

The FDA 510(k) record lists New Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SATURN 9000?

The FDA product code for SATURN 9000 is MQB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing New Medical 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.

K120380SATURN 8000K110210SATURN 8000-GSK080589SATURN 9000-810K072984SATURN 9000-550K072983SATURN 9000-750

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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