GALAXY SYSTEM; JUPITER


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K111055
Device Name GALAXY SYSTEM; JUPITER
Applicant
PERSONAL HEALTH INSTITUTE INTERNATIONAL
263 cedar creek drive
battle creek, 
MI 
49015

Applicant Contact kumar kulkarni
Correspondent
PERSONAL HEALTH INSTITUTE INTERNATIONAL
263 cedar creek drive
battle creek, 
MI 
49015

Correspodent Contact kumar kulkarni
Regulation Number 882.1400
Classification Product Code
OLV  
Date Received 04/15/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No