510(k) K092164
- Device
- TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
- Applicant
- SHENZHEN DELICATE ELECTRONICS CO., LTD.
- 510(k) number
- K092164
- Product code
- OQQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-13
- Date received
- 2009-07-16
- Regulation
- 892.1570
- Classification name
- Diagnostic Ultrasonic Transducer, Robotic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM STERN
- Address
- 1 Odell Plz. Yonkers NY US 10701 10701
FDA Registration Numbers#
- 3013368530
- 3006441164
- 3009286597
Source Documents#
Legacy Summary#
summary
FDA Review#
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