510(k) K894961
K894961 is an FDA 510(k) premarket notification submitted by Medisonic U.S.A., Inc. for the device "MEDISONIC ULTRA-SONIC INHALER". The FDA issued a decision of Substantially Equivalent on November 24, 1989. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medisonic U.S.A., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1989
- Date Received
- August 7, 1989
- 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