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Fukuda Denshi Dynascope (Ds-7000 Series Patient Monitor +4 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K083697
Identifiers
- 510(k) Number
- K083697 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
- Models / Variants
- Ds-7000 Series Patient Monitor FDA 510(k)Model Ds-7000 FDA 510(k)7000m FDA 510(k)7210 FDA 510(k)7210m FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fukuda Denshi Dynascope (Ds-7000 Series Patient Monitor +4 more) by Fukuda Denshi Usa, Inc. — 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 | K083697 | Class II | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Usa, Inc.
Sources (1)
- FDA 510(k) K083697 24 fields · synced Jun 19, 2026