The following data is part of a premarket notification filed by Biometrix Ltd. with the FDA for Art-line Single Channel Blood Pressure System, Art-line Double Channel Blood Pressure System, Art-line Triple Channel Blood Pressure System, Iap Monitoring Set With Disposable Transducer.
| Device ID | K151040 |
| 510k Number | K151040 |
| Device Name: | Art-line Single Channel Blood Pressure System, Art-line Double Channel Blood Pressure System, Art-line Triple Channel Blood Pressure System, IAP Monitoring Set With Disposable Transducer |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | BIOMETRIX LTD. KIRYAT MADA 4 Jerusalem, IL 91450 |
| Contact | Zoya Lee |
| Correspondent | Zoya Lee BIOMETRIX LTD. KIRYAT MADA 4 Jerusalem, IL 91450 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-09-04 |
| Summary: | summary |