ELPHA 2000 CONTI
FDA 510(k) clearance K964738 · decided 1997-08-14
Clearance details
- K-number
- K964738
- Device name
- ELPHA 2000 CONTI
- Applicant
- Dan Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-13
- Decision date
- 1997-08-14
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- KPI
- Device class
- 2
- Regulation number
- 876.5320
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.