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Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241…
FDA 510(k)Class II (US FDA 510(k))
510(k) K212257
Identifiers
- 510(k) Number
- K212257 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241… by Alicn Medical Shenzhen, Inc — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212257 | Class II | Active |
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Manufacturer
- Manufacturer
- Alicn Medical Shenzhen, Inc
- FDA Applicant
- Alicn Medical Shenzhen, Inc.
Sources (1)
- FDA 510(k) K212257 24 fields · synced Jun 19, 2026