Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K002316
Device Classification Name
Electroencephalograph
More FDA Info for this Device
510(K) Number
K002316
Device Name
Electroencephalograph
Applicant
AXON SYSTEMS, INC.
400-2200 OSER AVE.
HAUPPAUGE, NY 11788 US
Other 510(k) Applications for this Company
Contact
HOWARD BAILIN
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
GWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2000
Decision Date
10/26/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact