VITAPORT 3


the company

Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K000338
Device Name VITAPORT 3
Original Applicant
NIHON KOHDEN AMERICA, INC.
2601 campus dr.
irvine, 
CA 
92612 -1601

Original Contact bonnie bishop
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 02/03/2000
Decision Date 04/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No