Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K925364 |
Device Name |
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES |
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 | 868.2375
|
Classification Product Code |
|
Date Received | 10/22/1992 |
Decision Date | 01/28/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|