Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K133766 |
Device Name |
HUMICARE D900 |
Applicant |
GRUENDLER GMBH |
9001 SPECTRUM CENTER BLVD. |
SAN DIEGO,
CA
92123
|
|
Applicant Contact |
JIM CASSI |
Correspondent |
GRUENDLER GMBH |
9001 SPECTRUM CENTER BLVD. |
SAN DIEGO,
CA
92123
|
|
Correspondent Contact |
JIM CASSI |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 12/11/2013 |
Decision Date | 11/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|