Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K050990 |
Device Name |
REMREST HEATED HUMIDIFIER |
Applicant |
MEDICAL INDUSTRIES AMERICA, INC. |
2636 289TH PLACE |
ADEL,
IA
50003 -8021
|
|
Applicant Contact |
KEITH THEISEN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 04/19/2005 |
Decision Date | 05/02/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|