HEATER BASE, MODEL PMH7000


Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K080149
Device Name HEATER BASE, MODEL PMH7000
Applicant
PACIFIC MEDICO CO., LTD.
2-6-4hongo, bunkyo-ku,
tokyo, 

JP

113-0033

Applicant Contact yoshimo toyama
Correspondent
PACIFIC MEDICO CO., LTD.
2-6-4hongo, bunkyo-ku,
tokyo, 

JP

113-0033

Correspodent Contact yoshimo toyama
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 01/22/2008
Decision Date 12/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No