ELLIPSE 4
FDA 510(k) clearance K964522 · decided 1997-03-21
Clearance details
- K-number
- K964522
- Device name
- ELLIPSE 4
- Applicant
- Andromeda Medizinische Systeme GmbH
- Decision
- Substantially Equivalent
- Date received
- 1996-11-12
- Decision date
- 1997-03-21
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- FEN
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Potomac, MD, US
- Third-party review
- No
- Expedited review
- No
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| IN-PROBE II URODYNAMIC SYSTEM (K983325) | Influence, Inc. | 1998-11-24 |
| CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (K970595) | Circon Video | 1997-10-24 |
| LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (K971911) | Medamicus, Inc. | 1997-06-03 |
| DANTEC DUET (K960503) | Dantec Medical, Inc. | 1996-09-16 |
| LUMAX(MODIFICATION) (K953734) | Medamicus, Inc. | 1996-01-18 |
| LUMAX (MODIFICATION) (K954093) | Medamicus, Inc. | 1996-01-11 |
| PVC ABDOMINAL/RECTAL PRESSURE CATHETER (K954315) | Life-Tech Intl., Inc. | 1995-11-30 |
Recalls involving this device
No recalls on record reference this clearance.