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Nasal Pillow Mask - Small (NNPM-01/ Nefes S) +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K243225
Identifiers
- 510(k) Number
- K243225 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
- Models / Variants
- Nasal Pillow Mask - Small (NNPM-01/ Nefes S) FDA 510(k)Nasal Pillow Mask - Large (NNPM-03/ Nefes L) 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)
Nasal Pillow Mask - Small (NNPM-01/ Nefes S) +2 more models by Genadyne Biotechnologies, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K243225 | Class II | Active |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
Sources (1)
- FDA 510(k) K243225 24 fields · synced Jun 18, 2026