RXAIR 3000
FDA 510(k) clearance K951981 · decided 1995-10-12
Clearance details
- K-number
- K951981
- Device name
- RXAIR 3000
- Applicant
- Clean Air Research & Development
- Decision
- Substantially Equivalent
- Date received
- 1995-04-27
- Decision date
- 1995-10-12
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- FRA
- Device class
- 2
- Regulation number
- 880.6500
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.