STAT-SHELL DISPOSABLE SPO2 SENSOR


Device Classification Name

oximeter

510(k) Number K992092
Device Name STAT-SHELL DISPOSABLE SPO2 SENSOR
Applicant
EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10th st., suite 300
plano, 
TX 
75074

Applicant Contact krista oakes
Correspondent
EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10th st., suite 300
plano, 
TX 
75074

Correspodent Contact krista oakes
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 06/21/1999
Decision Date 12/22/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized