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Statim 7000 (without Usb Port) (01-702100 +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K072466
by Scican Ltd
Identifiers
- 510(k) Number
- K072466 FDA 510(k)
- FDA Product Code
- FLE FDA 510(k)
- Models / Variants
- 01-702100 FDA 510(k)Statim 7000 (with Usb Port) FDA 510(k)Model 01-702101 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6880 FDA 510(k)
- Regulation Number
- 880.6880 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Statim 7000 (without Usb Port) (01-702100 +2 more) by Scican Ltd — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K072466 | Class II | Active |
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Manufacturer
- Manufacturer
- Scican Ltd
- FDA Applicant
- Scican , Ltd.
Sources (1)
- FDA 510(k) K072466 24 fields · synced Jun 18, 2026