DRIVE SOLSTICE OXYGEN CONCENTRATOR


Device Classification Name

generator, oxygen, portable

510(k) Number K080391
Device Name DRIVE SOLSTICE OXYGEN CONCENTRATOR
Applicant
MEDICAL DEPOT
962 allegro lane
apollo beach, 
FL 
33572

Applicant Contact arthur ward
Regulation Number 868.5440
Classification Product Code
CAW  
Date Received 02/13/2008
Decision Date 03/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No