510(k) K012057
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2001
- Date Received
- July 2, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Bath, Hydro-Massage
- Device Class
- Class II
- Regulation Number
- 890.5100
- Review Panel
- PM
- Submission Type