510(k) K894632
- Device
- Model Ssh-140a Ultrasound Imaging System
- Applicant
- TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
- 510(k) number
- K894632
- Product code
- DXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-19
- Date received
- 1989-07-24
- Regulation
- 870.2330
- Classification name
- Echocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER BOHL
- Address
- 2441 Michelle Dr. P.O. Box 2068 Tustin CA US 92781 92781
FDA Registration Numbers#
- 3007738736
- 3019130
- 2134265
- 2124215
- 3007695959
- 3006382185
Source Documents#
510(k) summary PDF not indicated by FDA
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