HAND HELD NEBULIZER SYSTEM
FDA 510(k) clearance K884947 · decided 1989-02-17
Clearance details
- K-number
- K884947
- Device name
- HAND HELD NEBULIZER SYSTEM
- Applicant
- Salter Labs
- Decision
- Substantially Equivalent
- Date received
- 1988-11-25
- Decision date
- 1989-02-17
- Days to decision
- 84 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 |
|---|---|---|
| T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non- recall (Z-0796-2016) | Salter Labs | 2016-02-10 |