510(k) K081047
K081047 is an FDA 510(k) premarket notification submitted by Dornoch Medical Systems, Inc. for the device "TRANSPOSAL ULTRA SYSTEMS". The FDA issued a decision of Substantially Equivalent on April 29, 2008. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Dornoch Medical Systems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2008
- Date Received
- April 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type