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FDA 510(k)

HAIDA HD21

K-Number: K082288 · 2008-08-19

ApplicantJiangyin East China Medical Technology Co., Ltd.
Decision Date2008-08-19
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HAIDA HD21 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangyin East China Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2008-08-19 under 510(k) number K082288. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAIDA HD21?

HAIDA HD21 is a medical device that received FDA 510(k) clearance on 2008-08-19. The listed applicant is Jiangyin East China Medical Technology Co., Ltd.. The 510(k) number is K082288.

When did HAIDA HD21 receive FDA 510(k) clearance?

HAIDA HD21 received FDA 510(k) clearance on 2008-08-19, under 510(k) number K082288.

Who is the listed applicant for HAIDA HD21?

The FDA 510(k) record lists Jiangyin East China Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAIDA HD21?

The FDA product code for HAIDA HD21 is ITI.

Related Clinical Trials

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Other records listing Jiangyin East China Medical Technology Co., Ltd. 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.

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Related Devices (Code: ITI)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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