NEBULIZER PUMP, POWERED, MODEL 1110
FDA 510(k) clearance K925010 · decided 1994-05-27
Clearance details
- K-number
- K925010
- Device name
- NEBULIZER PUMP, POWERED, MODEL 1110
- Applicant
- Thomas Industries
- Decision
- Substantially Equivalent
- Date received
- 1992-10-02
- Decision date
- 1994-05-27
- Days to decision
- 602 days
- Clearance type
- Traditional
- Product code
- BTI
- Device class
- 2
- Regulation number
- 868.6250
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Sheboygan, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.