Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K861555 |
Device Name |
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT |
Applicant |
RESPIRATORY CARE, INC. |
900 W. UNIVERSITY |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
WILKE |
Correspondent |
RESPIRATORY CARE, INC. |
900 W. UNIVERSITY |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
WILKE |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 04/25/1986 |
Decision Date | 06/05/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|