Guangzhou Homesun Medical Technology Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 2 Latest Feb 21, 2024

Guangzhou Homesun Medical Technology Co., Ltd. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Guangzhou Homesun Medical Technology Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Guangzhou Homesun Medical Technology Co., Ltd." and its spelling variant "Guangzhou Homesun Medical Technology Co".

Latest 510(k)
Feb 21, 2024

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

2 510(k) clearances from Dec 6, 2019 to Feb 21, 2024.

K-NumberDeviceDate
K231561Pulmonary Function Tester, Model: A9Feb 21, 2024
K191239Smart Peak Flow MeterDec 6, 2019

Guangzhou Homesun Medical Technology Co., Ltd. and the FDA: common questions

Has Guangzhou Homesun Medical Technology Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Guangzhou Homesun Medical Technology Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Guangzhou Homesun Medical Technology Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Guangzhou Homesun Medical Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.