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FDA 510(k)

CONTRAST 7000 THERAPY SYSTEM

K-Number: K943497 · 1995-06-07

ApplicantBurke Neutech, Inc.
Decision Date1995-06-07
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CONTRAST 7000 THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Burke Neutech, Inc.. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K943497. 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 CONTRAST 7000 THERAPY SYSTEM?

CONTRAST 7000 THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Burke Neutech, Inc.. The 510(k) number is K943497.

When did CONTRAST 7000 THERAPY SYSTEM receive FDA 510(k) clearance?

CONTRAST 7000 THERAPY SYSTEM received FDA 510(k) clearance on 1995-06-07, under 510(k) number K943497.

Who is the listed applicant for CONTRAST 7000 THERAPY SYSTEM?

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

What is the FDA product code for CONTRAST 7000 THERAPY SYSTEM?

The FDA product code for CONTRAST 7000 THERAPY SYSTEM is ILO.

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Other records listing Burke Neutech, 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.

K955326SPORTS CONTRAST THERAPY SYSTEM ST 7000K952117EPILATORK945803THERMAFLEX, MODEL SD 55 C.P.M.H.K942926NEURO-AIDEK940160TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEMK926151LSI6000 THERMAL THERAPY SYSTEM

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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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