STAT-SHELL DISPOSABLE SP02 SENSOR


Device Classification Name

oximeter

510(k) Number K000831
Device Name STAT-SHELL DISPOSABLE SP02 SENSOR
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 03/14/2000
Decision Date 06/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No