Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K872113 |
Device Name |
OMNI-VENT, SERIES D |
Applicant |
STEIN-GATES MEDICAL EQUIPMENT, INC. |
121 NORTH FOURTH ST. |
ATCHISON,
KS
66002
|
|
Applicant Contact |
GATES, BS |
Correspondent |
STEIN-GATES MEDICAL EQUIPMENT, INC. |
121 NORTH FOURTH ST. |
ATCHISON,
KS
66002
|
|
Correspondent Contact |
GATES, BS |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/01/1987 |
Decision Date | 03/23/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|