VIGORMIST COMPRESSOR NEBULIZER
FDA 510(k) clearance K031413 · decided 2003-10-07
Clearance details
- K-number
- K031413
- Device name
- VIGORMIST COMPRESSOR NEBULIZER
- Applicant
- Vega Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-05
- Decision date
- 2003-10-07
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- BTI
- Device class
- 2
- Regulation number
- 868.6250
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Taipei, TW
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that recall (Z-1720-2015) | Compass Health Brands | 2015-06-06 |