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My Labs25 Gold/Mylab30 Gold Cardiovascular (7340 +4 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K091009
Identifiers
- 510(k) Number
- K091009 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
- Models / Variants
- 7340 FDA 510(k)My Lab70 FDA 510(k)My Lab70xvision FDA 510(k)Mylab60 FDA 510(k)Model 6150 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
My Labs25 Gold/Mylab30 Gold Cardiovascular (7340 +4 more) by Esaote S.p.A. — Class II — FDA_510K — listed in FDA 510(k) — 5 models
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 | K091009 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (1)
- FDA 510(k) K091009 24 fields · synced Jun 19, 2026