The following data is part of a premarket notification filed by Andromeda Medizinische Systeme Gmbh with the FDA for Ellipse 4.
| Device ID | K964522 |
| 510k Number | K964522 |
| Device Name: | ELLIPSE 4 |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | ANDROMEDA MEDIZINISCHE SYSTEME GMBH 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin, Ph.d. , Rac |
| Correspondent | Norman F Estrin, Ph.d. , Rac ANDROMEDA MEDIZINISCHE SYSTEME GMBH 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-03-21 |
| Summary: | summary |