Device Classification Name |
Humidifier, Non-Direct Patient Interface (Home-Use)
|
510(k) Number |
K810335 |
Device Name |
RESPIRIZER |
Applicant |
RESPIRIZER CO., DIV. CAMPILLARY SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RESPIRIZER CO., DIV. CAMPILLARY SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5460
|
Classification Product Code |
|
Date Received | 02/09/1981 |
Decision Date | 03/20/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|