SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
FDA 510(k) clearance K961476 · decided 1996-07-16
Clearance details
- K-number
- K961476
- Device name
- SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
- Applicant
- Salter Labs
- Decision
- Substantially Equivalent
- Date received
- 1996-04-18
- Decision date
- 1996-07-16
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Arvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to g recall (Z-2781-2015) | Salter Labs | 2015-09-17 |