Identifiers
- 510(k) Number
- K251105 FDA 510(k)
- FDA Product Code
- PKP FDA 510(k)
- Models / Variants
- Tetra (TM-20) FDA 510(k)Tetra (TM-50) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Tetra (TM-20) +1 more model by EMED Technologies Corporation — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS
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 | K251105 | Class II | Active |
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Manufacturer
- Manufacturer
- EMED Technologies Corporation
Sources (1)
- FDA 510(k) K251105 24 fields · synced Jun 19, 2026