DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
FDA 510(k) clearance K102023 · decided 2010-10-19
Clearance details
- K-number
- K102023
- Device name
- DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
- Applicant
- Shantou Institute of Ultrasonic Instruments (Siui
- Decision
- Substantially Equivalent
- Date received
- 2010-07-19
- Decision date
- 2010-10-19
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Dublin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.