NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM

Device Classification Name

unit, liquid-oxygen, portable

510(k) Number K033000
Device Name NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
Applicant
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 chivvis dr.
st. louis, 
MO 
63123

Applicant Contact elizabeth hunnicutt
Correspondent
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 chivvis dr.
st. louis, 
MO 
63123

Correspodent Contact elizabeth hunnicutt
Regulation Number 868.5655
Classification Product Code
BYJ  
Date Received 09/25/2003
Decision Date 03/22/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Expedited Review Yes

Combination Product

No