510(k) K933915
K933915 is an FDA 510(k) premarket notification submitted by Vortran Medical Technology 1, Inc. for the device "VENTI-GENTLE-HALER(TM)". The FDA issued a decision of Substantially Equivalent on October 28, 1993. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Vortran Medical Technology 1, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1993
- Date Received
- August 10, 1993
- 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