510(k) K102712
K102712 is an FDA 510(k) premarket notification submitted by Imed Technology, Inc. for the device "MED GRAVITY SET, IMED PUMP SET". The FDA issued a decision of Substantially Equivalent on Dec 16, 2011. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Imed Technology, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 2011
- Date Received
- Sep 20, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)