510(k) K030396
K030396 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "OMNI~NEB; OMNI~MAX". The FDA issued a decision of Substantially Equivalent on May 7, 2004. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2004
- Date Received
- February 6, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type