510(k) K900557
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1991
- Date Received
- February 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Device Class
- Class I
- Regulation Number
- 868.5640
- Review Panel
- AN
- Submission Type