510(k) K081062
K081062 is an FDA 510(k) premarket notification submitted by Airsonett, Inc. for the device "AIRSONNETT AIRSHOWER AIR 3". The FDA issued a decision of Substantially Equivalent on November 7, 2008. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045. Airsonett, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2008
- Date Received
- April 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type