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510(k) K923043

Device
SPECTRAL EEG MONITOR MODEL A1000
Applicant
ASPECT MEDICAL SYSTEMS, INC.
510(k) number
K923043
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-03
Date received
1992-06-24
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL J MANBERG
Address
770 Cochituate Rd. P.O. Box 9331 Framingham MA US 01701 01701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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