510(k) K063175
K063175 is an FDA 510(k) premarket notification submitted by Medical Technology Systems, Inc. for the device "IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)". The FDA issued a decision of Substantially Equivalent on March 14, 2008. The device falls under product code MOC (Cushion, Flotation, Therapeutic), a Class II device regulated under 21 CFR 890.5170. Medical Technology Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2008
- Date Received
- October 19, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Flotation, Therapeutic
- Device Class
- Class II
- Regulation Number
- 890.5170
- Review Panel
- PM
- Submission Type