DANTEC DA CAPO
FDA 510(k) clearance K953999 · decided 1995-11-21
Clearance details
- K-number
- K953999
- Device name
- DANTEC DA CAPO
- Applicant
- Dantec Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-24
- Decision date
- 1995-11-21
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- EXY
- Device class
- 2
- Regulation number
- 876.1800
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dantec Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Uroflowmeter (K142425) | Be Technologies, Inc. | 2014-10-27 |
| UROPOWER (K022721) | W.O.M. World of Medicine AG | 2003-08-26 |
| GR100F URINE FLOWMETER (K971913) | Albyn Medical , Ltd. | 1997-09-19 |
| FLOLAB (K951442) | Synectics Medical, Inc. | 1995-08-24 |
| URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (K944972) | Myo/Kinetic Systems, Inc. | 1995-03-08 |
| 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (K945495) | Fiberoptic Sensor Technlogies, Inc. | 1995-02-09 |
| UORCAP,MODEL NUMBER UDS-UCAP (K941105) | Laborie Medical Tech, Inc. | 1994-05-10 |
| MICROFLO (K904557) | Life-Tech Intl., Inc. | 1990-12-28 |
| DIAGNOSTIC ULTRASOUND UFS 1005 (K902408) | Diagnostic Ultrasound Corp. | 1990-08-10 |
| HOME URODATA SYSTEM(TM) (K900770) | Biodan Medical Systems, Ltd. | 1990-06-08 |
| ULTRACOMPACT (K894968) | Eutectic Electronics, Inc. | 1989-11-08 |
| MCT MEDICAL BROWNE UROSCAN URODYNAMIC (K880504) | Mct Medical, Inc. | 1988-06-17 |
Recalls involving this device
No recalls on record reference this clearance.