CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60


the company

Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K001213
Device Name CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
Original Applicant
HUDSON RESPIRATORY CARE, INC.
27711 diaz rd.
p.o. box 9020
temecula, 
CA 
92589 -9020

Original Contact dana houghton
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 04/14/2000
Decision Date 11/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No