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FDA 510(k)

TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT

K-Number: K080763 · 2008-05-30

ApplicantTalley Medical
Decision Date2008-05-30
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT is the device name listed in this FDA 510(k) record. The listed applicant is Talley Medical. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K080763. 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 TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT?

TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is Talley Medical. The 510(k) number is K080763.

When did TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT receive FDA 510(k) clearance?

TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT received FDA 510(k) clearance on 2008-05-30, under 510(k) number K080763.

Who is the listed applicant for TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT?

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

What is the FDA product code for TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT?

The FDA product code for TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT is DWJ.

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Other records listing Talley 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.

K090258VENTURI NPWT V. II ADVANCED VACUUM SYSTEMK080897VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM

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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