510(k) K081740
K081740 is an FDA 510(k) premarket notification submitted by Innovations For Access, Inc. for the device "HEMOBAND, MODELS HB-NS AND HB-NSXL". The FDA issued a decision of Substantially Equivalent on March 12, 2009. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2009
- Date Received
- June 19, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type