Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K853084 |
Device Name |
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) |
Applicant |
AEQUITRON MEDICAL, INC. |
14800 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447 -4834
|
|
Applicant Contact |
ROBERT C SAMEC |
Correspondent |
AEQUITRON MEDICAL, INC. |
14800 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447 -4834
|
|
Correspondent Contact |
ROBERT C SAMEC |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/23/1985 |
Decision Date | 08/02/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|