510(k) K931594
K931594 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 1993. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1993
- Date Received
- March 31, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Flotation Therapy, Powered
- Device Class
- Class II
- Regulation Number
- 890.5170
- Review Panel
- PM
- Submission Type