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Proair 3000 Compression System
FDA 510(k)Class II (US FDA 510(k))
510(k) K993758
Identifiers
- 510(k) Number
- K993758 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PROAIR 3000 Compression System is a high-quality, clinically proven device designed to provide optimal compression therapy for patients with cardiovascular conditions. Its advanced features and rigorous testing ensure effective treatment outcomes while minimizing side effects.
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 | K993758 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Compression Systems (Dbn) , Ltd.
Sources (1)
- FDA 510(k) K993758 24 fields · synced Jul 14, 2026