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Tungsten Eyeshield
FDA 510(k)Class I (US FDA 510(k))
510(k) K943011
by Medtec LLC
Identifiers
- 510(k) Number
- K943011 FDA 510(k)
- FDA Product Code
- IWS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.6500 FDA 510(k)
- Regulation Number
- 892.6500 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Tungsten Eyeshield by Medtec LLC — Class I — FDA_510K — listed in FDA 510(k) — 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 | K943011 | Class I | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- FDA Applicant
- Medtec, Inc.
Sources (1)
- FDA 510(k) K943011 24 fields · synced Jun 19, 2026