510(k) K904718
K904718 is an FDA 510(k) premarket notification submitted by Tri/Bor Medical, Inc. for the device "AERO-GEN NUBULIZER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 1, 1991. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Tri/Bor Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1991
- Date Received
- October 18, 1990
- 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