510(k) K781475
- Device
- ELECTRODE IMPEDANCE TESTER-MODEL 500
- Applicant
- LIFE-TECH INSTRUMENTS, INC.
- 510(k) number
- K781475
- Product code
- GYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-09-07
- Date received
- 1978-08-28
- Regulation
- 882.1410
- Classification name
- Tester, Electrode/lead, Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007048259
- 3014649088
- 2436826
- 3016852448
- 2080783
- 3010900508
- 3013501110
- 9611252
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GYA #
Legacy Summary#
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FDA Review#
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