510(k) K860875
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 1986
- Date Received
- February 25, 1986
- 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