Device Classification Name |
valve, non-rebreathing
|
510(k) Number |
K855218 |
Device Name |
RONDEX CPR VALVE |
Applicant |
KONDEX PRODUCTS, INC. |
P.O. BOX NO 1829 |
ROCKFORD,
IL
61110
|
|
Applicant Contact |
GENE R BALDWIN |
Correspondent |
KONDEX PRODUCTS, INC. |
P.O. BOX NO 1829 |
ROCKFORD,
IL
61110
|
|
Correspondent Contact |
GENE R BALDWIN |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 12/30/1985 |
Decision Date | 02/12/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|