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7600 Series Reusable Full-Face Cpap/Nippv Masks (7620 Large +4 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K020759
Identifiers
- 510(k) Number
- K020759 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
- Models / Variants
- 7620 Large FDA 510(k)7630 Medium FDA 510(k)7640 Small FDA 510(k)7650 Extra Small FDA 510(k)7660 Petit FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
7600 Series Reusable Full-Face Cpap/Nippv Masks (7620 Large +4 more) by Hans Rudolph, 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 | K020759 | Class II | Active |
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Manufacturer
- Manufacturer
- Hans Rudolph, Inc.
Sources (1)
- FDA 510(k) K020759 24 fields · synced Jun 19, 2026