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SAKURA STEAM STERILIZAER MODEL ASSV-AH06 - Skytron Integrity 175
FDA 510(k)Class II (US FDA 510(k))
510(k) K122774
Identifiers
- 510(k) Number
- K122774 FDA 510(k)
- FDA Product Code
- FLE FDA 510(k)
- Models / Variants
- Sakura Steam Sterilizaer Model Assv-Ah06 FDA 510(k)Sakura Steam Sterilizer Model Assv-Ah06e FDA 510(k)Skytron Integrity 175 FDA 510(k)Skytron Integ 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)
SAKURA STEAM STERILIZAER MODEL ASSV-AH06 - Skytron Integrity 175 by Sakura Seiki Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K122774 | Class II | Active |
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Manufacturer
- Manufacturer
- Sakura Seiki Co., Ltd.
Sources (1)
- FDA 510(k) K122774 24 fields · synced Jun 18, 2026