510(k) K060439
K060439 is an FDA 510(k) premarket notification submitted by Medical Acoustics, LLC for the device "LUNG FLUTE". The FDA issued a decision of Substantially Equivalent on June 22, 2006. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Medical Acoustics, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2006
- Date Received
- February 21, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percussor, Powered-Electric
- Device Class
- Class II
- Regulation Number
- 868.5665
- Review Panel
- AN
- Submission Type