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510(k) K001324

Device
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
Applicant
NEURO SCAN LABS
510(k) number
K001324
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2000-07-11
Date received
2000-04-26
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
DAVID B JONES
Address
5700 Cromo Dr. Suite 100 El Paso TX US 79912 79912

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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