Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K915228 |
Device Name |
DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL |
Applicant |
HOSPITAK, INC. |
1144 ROUTE 109 |
LINDENHURST,
NY
11757
|
|
Applicant Contact |
WILLIAM J LACEY |
Correspondent |
HOSPITAK, INC. |
1144 ROUTE 109 |
LINDENHURST,
NY
11757
|
|
Correspondent Contact |
WILLIAM J LACEY |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 11/20/1991 |
Decision Date | 02/11/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|