510(k) K001461
K001461 is an FDA 510(k) premarket notification submitted by Biometrix , Ltd. for the device "TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET". The FDA issued a decision of Substantially Equivalent on September 11, 2000. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Biometrix , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2000
- Date Received
- May 10, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type