Proair 3000 Compression System
by Medical Compression Systems (Dbn), Ltd.
510(k) K993758
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
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Overview
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.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993758 | Date19 May 2000 | StatusActive |
Official records
- FDA 510(k) database K993758
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOW
- FDA applicant
- Medical Compression Systems (Dbn) , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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