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FDA 510(k)

SCOUT

K-Number: K982158 · 1998-08-31

ApplicantBurke, Inc.
Decision Date1998-08-31
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SCOUT is the device name listed in this FDA 510(k) record. The listed applicant is Burke, Inc.. It received FDA 510(k) clearance on 1998-08-31 under 510(k) number K982158. 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 SCOUT?

SCOUT is a medical device that received FDA 510(k) clearance on 1998-08-31. The listed applicant is Burke, Inc.. The 510(k) number is K982158.

When did SCOUT receive FDA 510(k) clearance?

SCOUT received FDA 510(k) clearance on 1998-08-31, under 510(k) number K982158.

Who is the listed applicant for SCOUT?

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

What is the FDA product code for SCOUT?

The FDA product code for SCOUT is ITI.

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Other records listing Burke, 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.

K061912FUSIONK023961SCOUT BOSSK965123PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)K911943CONCEPT MODEL 5200 THERMAL THERAPY SYSTEMK893706COLD/HOT FLUID RADIATION PAD NEUTECHK834506PACESAVER & SCOUT

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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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