510(k) K843355
- Device
- TRANSDUCER FOR KONTROL 5MHZ SIGMA 20
- Applicant
- KONTRON INSTRUMENTS, INC.
- 510(k) number
- K843355
- Product code
- MHZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-03
- Date received
- 1984-08-27
- Regulation
- 510(k) Premarket Notification
- Classification name
- Stimulator, Vestibular Acceleration, Therapeutic
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Neurology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE CHO
- Address
- 9 Plymouth St. Everett MA US 02149 02149
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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