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FDA 510(k)

RANGER(II)

K-Number: K852813 · 1985-08-22

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

Device Summary

RANGER(II) 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 K852813. 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(II)?

RANGER(II) 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 K852813.

When did RANGER(II) receive FDA 510(k) clearance?

RANGER(II) received FDA 510(k) clearance on 1985-08-22, under 510(k) number K852813.

Who is the listed applicant for RANGER(II)?

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(II)?

The FDA product code for RANGER(II) 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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