The following data is part of a premarket notification filed by Florence Medical Ltd. with the FDA for Smartflow, Model Sfip 2000.
| Device ID | K003122 |
| 510k Number | K003122 |
| Device Name: | SMARTFLOW, MODEL SFIP 2000 |
| Classification | Computer, Blood-pressure |
| Applicant | FLORENCE MEDICAL LTD. 117 AHUZAH ST. Ra'ananna 43373, IL 43373 |
| Contact | Shoshana Freidman, Rac |
| Correspondent | Shoshana Freidman, Rac FLORENCE MEDICAL LTD. 117 AHUZAH ST. Ra'ananna 43373, IL 43373 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-05 |
| Decision Date | 2001-05-14 |