The following data is part of a premarket notification filed by Florence Medical Ltd. with the FDA for Smartflow Pulse Transmission Coefficient.
| Device ID | K020127 |
| 510k Number | K020127 |
| Device Name: | SMARTFLOW PULSE TRANSMISSION COEFFICIENT |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | FLORENCE MEDICAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Orly Maor |
| Correspondent | Orly Maor FLORENCE MEDICAL LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-15 |
| Decision Date | 2002-02-14 |
| Summary: | summary |