Device Classification Name |
Calibrator, Pressure, Gas
|
510(k) Number |
K923397 |
Device Name |
SINGLE DOSE GAS INJECTOR |
Applicant |
ESCALON MEDICAL TREK |
820 SWAN DR. |
MUKWONAGO,
WI
53149
|
|
Applicant Contact |
RONALD HUENEKE |
Correspondent |
ESCALON MEDICAL TREK |
820 SWAN DR. |
MUKWONAGO,
WI
53149
|
|
Correspondent Contact |
RONALD HUENEKE |
Regulation Number | 868.2620
|
Classification Product Code |
|
Date Received | 07/10/1992 |
Decision Date | 09/14/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|