Device Classification Name |
set, tubing and support, ventilator (w harness)
|
510(k) Number |
K861286 |
Device Name |
GAS SAMPLING KIT |
Applicant |
RESPIRATORY SUPPORT PRODUCTS, INC. |
3183-D AIRWAY AVE. |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
ANTHONY V BERAN |
Correspondent |
RESPIRATORY SUPPORT PRODUCTS, INC. |
3183-D AIRWAY AVE. |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
ANTHONY V BERAN |
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 04/07/1986 |
Decision Date | 04/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|