The following data is part of a premarket notification filed by Biometrix Ltd. with the FDA for Tpn Nutrition Bag (eva), Emptying Tube, Bag Syringe Fill Set.
| Device ID | K001461 |
| 510k Number | K001461 |
| Device Name: | TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET |
| Classification | Container, I.v. |
| Applicant | BIOMETRIX LTD. 4 KIRYAT MADA P.O. BOX 45057 Jerusalem, IL 91450 |
| Contact | Miriam Abutbul |
| Correspondent | Miriam Abutbul BIOMETRIX LTD. 4 KIRYAT MADA P.O. BOX 45057 Jerusalem, IL 91450 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-10 |
| Decision Date | 2000-09-11 |