SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
FDA 510(k) clearance K050099 · decided 2005-01-28
Clearance details
- K-number
- K050099
- Device name
- SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
- Applicant
- Kontron Medical Systems Sas
- Decision
- Substantially Equivalent
- Date received
- 2005-01-18
- Decision date
- 2005-01-28
- Days to decision
- 10 days
- Clearance type
- Abbreviated
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wanaque, NJ, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.