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FDA 510(k)

DELTA THERM COLD THERAPY SYSTEM

K-Number: K945399 · 1995-03-07

ApplicantDeltatherm
Decision Date1995-03-07
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

DELTA THERM COLD THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Deltatherm. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K945399. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DELTA THERM COLD THERAPY SYSTEM?

DELTA THERM COLD THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Deltatherm. The 510(k) number is K945399.

When did DELTA THERM COLD THERAPY SYSTEM receive FDA 510(k) clearance?

DELTA THERM COLD THERAPY SYSTEM received FDA 510(k) clearance on 1995-03-07, under 510(k) number K945399.

Who is the listed applicant for DELTA THERM COLD THERAPY SYSTEM?

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

What is the FDA product code for DELTA THERM COLD THERAPY SYSTEM?

The FDA product code for DELTA THERM COLD THERAPY SYSTEM is ILO.

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Related Devices (Code: ILO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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