510(k) K101940
K101940 is an FDA 510(k) premarket notification submitted by Equashield Medical , Ltd. for the device "EQUASHIELD SYSTEM PROTECTIVE PLUS". The FDA issued a decision of Substantially Equivalent on November 19, 2010. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Equashield Medical , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2010
- Date Received
- July 12, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type