MABIS NB-02 ULTRASONIC NEBULIZER
FDA 510(k) clearance K990506 · decided 1999-03-11
Clearance details
- K-number
- K990506
- Device name
- MABIS NB-02 ULTRASONIC NEBULIZER
- Applicant
- Mabis Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-17
- Decision date
- 1999-03-11
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lake Forest, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.