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FDA 510(k)

HUBANG, MODEL HBL13/HBG12-S

K-Number: K083044 · 2008-12-12

ApplicantShanghai Hubang Medical Appliances Co., Ltd.
Decision Date2008-12-12
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HUBANG, MODEL HBL13/HBG12-S is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Hubang Medical Appliances Co., Ltd.. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K083044. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUBANG, MODEL HBL13/HBG12-S?

HUBANG, MODEL HBL13/HBG12-S is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Shanghai Hubang Medical Appliances Co., Ltd.. The 510(k) number is K083044.

When did HUBANG, MODEL HBL13/HBG12-S receive FDA 510(k) clearance?

HUBANG, MODEL HBL13/HBG12-S received FDA 510(k) clearance on 2008-12-12, under 510(k) number K083044.

Who is the listed applicant for HUBANG, MODEL HBL13/HBG12-S?

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

What is the FDA product code for HUBANG, MODEL HBL13/HBG12-S?

The FDA product code for HUBANG, MODEL HBL13/HBG12-S is IOR.

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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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