The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Home Urodata System(tm).
| Device ID | K900770 |
| 510k Number | K900770 |
| Device Name: | HOME URODATA SYSTEM(TM) |
| Classification | Uroflowmeter |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. P.O.B. 2012 REHOVOT 76120 Israel, IL |
| Contact | Marc Coles |
| Correspondent | Marc Coles BIODAN MEDICAL SYSTEMS, LTD. P.O.B. 2012 REHOVOT 76120 Israel, IL |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-06-08 |