TENACORE OXYGEN BLENDER, MODEL TB-2000


Device Classification Name

mixer, breathing gases, anesthesia inhalation

510(k) Number K081335
Device Name TENACORE OXYGEN BLENDER, MODEL TB-2000
Applicant
TENACORE HOLDINGS, INC.
647 east young st.
santa ana, 
CA 
92705

Applicant Contact brand caso
Correspondent
TENACORE HOLDINGS, INC.
647 east young st.
santa ana, 
CA 
92705

Correspodent Contact brand caso
Regulation Number 868.5330
Classification Product Code
BZR  
Date Received 05/12/2008
Decision Date 11/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No