510(k) K823327
K823327 is an FDA 510(k) premarket notification submitted by Wall Manufacturer, Inc. for the device "PORTABLE SHOWER BATH". The FDA issued a decision of Substantially Equivalent on December 7, 1982. The device falls under product code ILM (Bath, Sitz, Powered), a Class II device regulated under 21 CFR 890.5100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1982
- Date Received
- November 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Sitz, Powered
- Device Class
- Class II
- Regulation Number
- 890.5100
- Review Panel
- PM
- Submission Type