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510(k) K000068

Device
COMPUMEDICS E-SERIES EEG SYSTEM
Applicant
COMPUMEDICS NEURO SCIENCE PTY LTD.
510(k) number
K000068
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2000-03-13
Date received
2000-01-10
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CONSTANCE G BUNDY
Address
6470 Riverview Ter. Findley MN US 55432 55432

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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