Warning letter
ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD: warning letter of Jun 4, 2021
FDA warning letter 612946 · Center for Devices and Radiological Health
Key facts
| Reference number | 612946 |
|---|---|
| Company | ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Jun 4, 2021 |
| Posted date | Jul 6, 2021 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.39 |
| Country | 1 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: