The following data is part of a premarket notification filed by Biometrix Ltd. with the FDA for Pvc Free Intravascular Administration Set.
| Device ID | K011216 |
| 510k Number | K011216 |
| Device Name: | PVC FREE INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-20 |
| Decision Date | 2001-07-18 |