Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K925262 |
Device Name |
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
8102 WOODLAND DR/. |
INDIANAPOLIS,
IN
46278
|
|
Applicant Contact |
ROBERT RICHMOND |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
8102 WOODLAND DR/. |
INDIANAPOLIS,
IN
46278
|
|
Correspondent Contact |
ROBERT RICHMOND |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 10/19/1992 |
Decision Date | 01/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|