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FDA 510(k)

ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY

K-Number: K964799 · 1997-08-29

ApplicantOrmed GmbH
Decision Date1997-08-29
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Ormed GmbH. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K964799. 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 ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY?

ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Ormed GmbH. The 510(k) number is K964799.

When did ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY receive FDA 510(k) clearance?

ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY received FDA 510(k) clearance on 1997-08-29, under 510(k) number K964799.

Who is the listed applicant for ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY?

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

What is the FDA product code for ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY?

The FDA product code for ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY is ILO.

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Other records listing Ormed GmbH 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.

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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.

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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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