510(k) K112502
K112502 is an FDA 510(k) premarket notification submitted by Hill-Rom Co. for the device "PROCEDURAL STRECHER WITH INTELLIDRIVE P8000". The FDA issued a decision of Substantially Equivalent on September 19, 2011. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690. Hill-Rom Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2011
- Date Received
- August 30, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stretcher, Wheeled, Powered
- Device Class
- Class II
- Regulation Number
- 890.3690
- Review Panel
- PM
- Submission Type