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FDA 510(k)

COLD/HOT FLUID RADIATION PAD NEUTECH

K-Number: K893706 · 1989-06-22

ApplicantBurke, Inc.
Decision Date1989-06-22
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLD/HOT FLUID RADIATION PAD NEUTECH is the device name listed in this FDA 510(k) record. The listed applicant is Burke, Inc.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K893706. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLD/HOT FLUID RADIATION PAD NEUTECH?

COLD/HOT FLUID RADIATION PAD NEUTECH is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Burke, Inc.. The 510(k) number is K893706.

When did COLD/HOT FLUID RADIATION PAD NEUTECH receive FDA 510(k) clearance?

COLD/HOT FLUID RADIATION PAD NEUTECH received FDA 510(k) clearance on 1989-06-22, under 510(k) number K893706.

Who is the listed applicant for COLD/HOT FLUID RADIATION PAD NEUTECH?

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 COLD/HOT FLUID RADIATION PAD NEUTECH?

The FDA product code for COLD/HOT FLUID RADIATION PAD NEUTECH is ILO.

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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 BOSSK982158SCOUTK965123PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)K911943CONCEPT MODEL 5200 THERMAL THERAPY SYSTEMK834506PACESAVER & SCOUT

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Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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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