Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K122705 |
Device Name |
HUMICARE D900 |
Applicant |
GRUNDLER GMBH |
9001 SPECTRUM CENTER BLVD |
SAN DIEGO,
CA
92123
|
|
Applicant Contact |
JIM CASSI |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
OLAF TEICHERT |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 05/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|