The following data is part of a premarket notification filed by Browne Medical Systems, Inc. with the FDA for Browne Medical Systems Imagepro.
| Device ID | K910444 |
| 510k Number | K910444 |
| Device Name: | BROWNE MEDICAL SYSTEMS IMAGEPRO |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis, MN 55433 |
| Contact | Deborah Hall |
| Correspondent | Deborah Hall BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis, MN 55433 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1991-06-10 |