The following data is part of a premarket notification filed by Biosonix Ltd. with the FDA for Flowguard Device.
| Device ID | K013803 |
| 510k Number | K013803 |
| Device Name: | FLOWGUARD DEVICE |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | BIOSONIX LTD. BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein BIOSONIX LTD. BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-15 |
| Decision Date | 2002-02-13 |
| Summary: | summary |