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FDA 510(k)

ARTOCOOL-S WATER CIRCULATING COLD PACK

K-Number: K964354 · 1997-08-29

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

Device Summary

ARTOCOOL-S WATER CIRCULATING COLD PACK 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 K964354. 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 ARTOCOOL-S WATER CIRCULATING COLD PACK?

ARTOCOOL-S WATER CIRCULATING COLD PACK 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 K964354.

When did ARTOCOOL-S WATER CIRCULATING COLD PACK receive FDA 510(k) clearance?

ARTOCOOL-S WATER CIRCULATING COLD PACK received FDA 510(k) clearance on 1997-08-29, under 510(k) number K964354.

Who is the listed applicant for ARTOCOOL-S WATER CIRCULATING COLD PACK?

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 ARTOCOOL-S WATER CIRCULATING COLD PACK?

The FDA product code for ARTOCOOL-S WATER CIRCULATING COLD PACK 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.

K964799ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY

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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