Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K010728
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K010728
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
STELLATE SYSTEMS
345 VICTORIA AVE., SUITE 300
WESTMOUNT, QUEBEC H3Z 2N2 CA
Other 510(k) Applications for this Company
Contact
GEORGE PAPAGIANNIS
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/2001
Decision Date
05/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact