(SPAG) MODEL SPAG-2 6000 SERIES
FDA 510(k) clearance K871427 · decided 1987-10-06
Clearance details
- K-number
- K871427
- Device name
- (SPAG) MODEL SPAG-2 6000 SERIES
- Applicant
- Viratek, Inc.
- Decision
- Unknown
- Date received
- 1987-04-09
- Decision date
- 1987-10-06
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 recall (Z-0674-2016) | Valeant Pharmacueticals International | 2016-01-21 |
| Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generat recall (Z-0371-2016) | Valeant Pharmaceuticals North America LLC | 2015-12-04 |