OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD


information about

Device Classification Name

oximeter

510(k) Number K002036
Device Name OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
Original Applicant
OSI MEDICAL, INC.
13801 mccormick dr.
tampa, 
FL 
33626

Original Contact james r levani
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 07/05/2000
Decision Date 04/17/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No