510(k) K914583
- Device
- TOSBEE
- Applicant
- TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
- 510(k) number
- K914583
- Product code
- IYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-01-28
- Date received
- 1991-10-16
- Regulation
- 892.5900
- Classification name
- Generator, Low Voltage, Therapeutic X-ray
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMOTHY W CAPEHART
- Address
- 2441 Michelle Dr. P.O. Box 2068 Tustin CA US 92781 92781
Source Documents#
Legacy Summary#
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FDA Review#
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