Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K142825
Device Classification Name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K142825
Device Name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant
CONSOLIDATED RESEARCH OF RICHMOND, INC
26250 EUCLID AVE
SUITE 709
EUCLID, OH 44132 US
Other 510(k) Applications for this Company
Contact
Richard Kaplan
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2014
Decision Date
01/20/2015
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