Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K952512 |
Device Name |
CAPNO-FLO REGULATOR, CAPNO-FLO |
Applicant |
KIRK SPECIALTY SYSTEMS |
1625 CRESCENT CIR., STE. 225 |
CARROLLTON,
TX
75006
|
|
Applicant Contact |
DALE BICKLEY |
Correspondent |
KIRK SPECIALTY SYSTEMS |
1625 CRESCENT CIR., STE. 225 |
CARROLLTON,
TX
75006
|
|
Correspondent Contact |
DALE BICKLEY |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 05/30/1995 |
Decision Date | 08/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|