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FDA 510(k)

SYSTEM 70 AND 100

K-Number: K904246 · 1991-06-10

ApplicantFolio Products, Inc.
Decision Date1991-06-10
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SYSTEM 70 AND 100 is the device name listed in this FDA 510(k) record. The listed applicant is Folio Products, Inc.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K904246. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 70 AND 100?

SYSTEM 70 AND 100 is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Folio Products, Inc.. The 510(k) number is K904246.

When did SYSTEM 70 AND 100 receive FDA 510(k) clearance?

SYSTEM 70 AND 100 received FDA 510(k) clearance on 1991-06-10, under 510(k) number K904246.

Who is the listed applicant for SYSTEM 70 AND 100?

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

What is the FDA product code for SYSTEM 70 AND 100?

The FDA product code for SYSTEM 70 AND 100 is ITI.

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 Folio Products, 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.

K905292SYSTEM 50K905293SYSTEM 90 AND 95

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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.

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