ELPHA 2000 CONTI— 510(k) K964738
Substantially EquivalentDan Med, Inc.
FDA 510(k) clearance K964738 for ELPHA 2000 CONTI, Substantially Equivalent on 1997-08-14. Applicant: Dan Med, Inc.. Device class: 2.
Clearance details
- Applicant
- Dan Med, Inc.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
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More clearances from Dan Med, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.