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FDA 510(k)

Pulmonary Function Tester, Model: A9

K-Number: K231561 · 2024-02-21

ApplicantGuangzhou Homesun Medical Technology Co., Ltd.
Decision Date2024-02-21
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pulmonary Function Tester, Model: A9 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Homesun Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-21 under 510(k) number K231561. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulmonary Function Tester, Model: A9?

Pulmonary Function Tester, Model: A9 is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is Guangzhou Homesun Medical Technology Co., Ltd.. The 510(k) number is K231561.

When did Pulmonary Function Tester, Model: A9 receive FDA 510(k) clearance?

Pulmonary Function Tester, Model: A9 received FDA 510(k) clearance on 2024-02-21, under 510(k) number K231561.

Who is the listed applicant for Pulmonary Function Tester, Model: A9?

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

What is the FDA product code for Pulmonary Function Tester, Model: A9?

The FDA product code for Pulmonary Function Tester, Model: A9 is BTY.

Other records listing Guangzhou Homesun 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.

K191239Smart Peak Flow Meter

Related Devices (Code: BTY)

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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