510(k) K041503
K041503 is an FDA 510(k) premarket notification submitted by D.T. Davis Enterprises , Ltd. for the device "HOVERJACK AIR PATIENT LIFT DEVICE". The FDA issued a decision of Substantially Equivalent on August 12, 2004. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2004
- Date Received
- June 7, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lift, Patient, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 880.5500
- Review Panel
- HO
- Submission Type