510(k) K110994
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2011
- Date Received
- April 8, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Hydro-Massage
- Device Class
- Class II
- Regulation Number
- 890.5100
- Review Panel
- PM
- Submission Type