TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
FDA 510(k) clearance K092164 · decided 2010-05-13
Clearance details
- K-number
- K092164
- Device name
- TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
- Applicant
- Shenzhen Delicate Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-16
- Decision date
- 2010-05-13
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- OQQ
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Yonkers, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.