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FDA 510(k)

THERMO BUDDY, MODELS TB-100, TB-110, TB-120

K-Number: K023412 · 2003-04-09

ApplicantHubdic Co., Ltd.
Decision Date2003-04-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMO BUDDY, MODELS TB-100, TB-110, TB-120 is the device name listed in this FDA 510(k) record. The listed applicant is Hubdic Co., Ltd.. It received FDA 510(k) clearance on 2003-04-09 under 510(k) number K023412. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO BUDDY, MODELS TB-100, TB-110, TB-120?

THERMO BUDDY, MODELS TB-100, TB-110, TB-120 is a medical device that received FDA 510(k) clearance on 2003-04-09. The listed applicant is Hubdic Co., Ltd.. The 510(k) number is K023412.

When did THERMO BUDDY, MODELS TB-100, TB-110, TB-120 receive FDA 510(k) clearance?

THERMO BUDDY, MODELS TB-100, TB-110, TB-120 received FDA 510(k) clearance on 2003-04-09, under 510(k) number K023412.

Who is the listed applicant for THERMO BUDDY, MODELS TB-100, TB-110, TB-120?

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

What is the FDA product code for THERMO BUDDY, MODELS TB-100, TB-110, TB-120?

The FDA product code for THERMO BUDDY, MODELS TB-100, TB-110, TB-120 is FLL.

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Other records listing Hubdic Co., Ltd. as applicant

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Related Devices (Code: FLL)

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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