PACIFICA


Device Classification Name

oximeter, tissue saturation

510(k) Number K073407
Device Name PACIFICA
Applicant
OR-NIM MEDICAL LTD.
2001 pennsylvania ave. nw
suite 950
washington, 
DC 
20006

Applicant Contact campbell hutton
Correspondent
OR-NIM MEDICAL LTD.
2001 pennsylvania ave. nw
suite 950
washington, 
DC 
20006

Correspodent Contact campbell hutton
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 12/04/2007
Decision Date 02/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No