510(k) K853163
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1985
- Date Received
- July 30, 1985
- Clearance Type
- Traditional
- 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