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FDA 510(k)

RANGER-X

K-Number: K852811 · 1985-08-22

ApplicantInvacare Corp.
Decision Date1985-08-22
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RANGER-X is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 1985-08-22 under 510(k) number K852811. 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 RANGER-X?

RANGER-X is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is Invacare Corp.. The 510(k) number is K852811.

When did RANGER-X receive FDA 510(k) clearance?

RANGER-X received FDA 510(k) clearance on 1985-08-22, under 510(k) number K852811.

Who is the listed applicant for RANGER-X?

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

What is the FDA product code for RANGER-X?

The FDA product code for RANGER-X is ITI.

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Other records listing Invacare Corp. 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.

K071928THE INVACARE FLYER, MODEL IPC 100K070321TWILIGHT FULL FACE MASKK062402EASYSTAND EVOLVK061874INVACARE'S TWILIGHT II NASAL MASKSK033819INVACARE 3G TARSYSK031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

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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

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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