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FDA 510(k)

COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1

K-Number: K061902 · 2006-12-08

ApplicantInditherm Medical
Decision Date2006-12-08
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 is the device name listed in this FDA 510(k) record. The listed applicant is Inditherm Medical. It received FDA 510(k) clearance on 2006-12-08 under 510(k) number K061902. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1?

COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 is a medical device that received FDA 510(k) clearance on 2006-12-08. The listed applicant is Inditherm Medical. The 510(k) number is K061902.

When did COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 receive FDA 510(k) clearance?

COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 received FDA 510(k) clearance on 2006-12-08, under 510(k) number K061902.

Who is the listed applicant for COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1?

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

What is the FDA product code for COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1?

The FDA product code for COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 is DWJ.

Related Clinical Trials

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Other records listing Inditherm Medical 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.

K051419INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1

Related Devices (Code: DWJ)

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.

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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