EPIC SPO2 FINGER SENSOR, MODEL E412-20


definition

Device Classification Name

oximeter

510(k) Number K002223
Device Name EPIC SPO2 FINGER SENSOR, MODEL E412-20
Original Applicant
EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10th st., suite 300
plano, 
TX 
75074

Original Contact krista oakes
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 07/24/2000
Decision Date 08/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No