The following data is part of a premarket notification filed by Browne Medical Systems, Inc. with the FDA for Image Pro Urodynamics Measuring Syst, Modification.
Device ID | K920991 |
510k Number | K920991 |
Device Name: | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION |
Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Applicant | BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis, MN 55433 |
Contact | Al Sherwood |
Correspondent | Al Sherwood 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 | 1992-02-14 |
Decision Date | 1992-04-10 |