CAIRE COMPANION 5 OXYGEN CONCENTRATOR


Device Classification Name

generator, oxygen, portable

510(k) Number K121167
Device Name CAIRE COMPANION 5 OXYGEN CONCENTRATOR
Applicant
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground, 
GA 
30107

Applicant Contact ben kadrlik
Regulation Number 868.5440
Classification Product Code
CAW  
Date Received 04/17/2012
Decision Date 05/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No