Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K843970 |
Device Name |
MODEL IM1074 END-TIDAL CO2 MODULE |
Applicant |
GOULD, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Applicant Contact |
ARCHER S GORDON |
Correspondent |
GOULD, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent Contact |
ARCHER S GORDON |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 10/11/1984 |
Decision Date | 10/24/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|