DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER


Device Classification Name

oximeter

510(k) Number K024235
Device Name DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
Original Applicant
DOLPHIN MEDICAL INC.
13801 mccormick dr.
tampa, 
FL 
33626

Original Contact jon werner
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 12/23/2002
Decision Date 03/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No