Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K860455 |
Device Name |
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING |
Applicant |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Applicant Contact |
ALAN P SCHWARTZ |
Correspondent |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Correspondent Contact |
ALAN P SCHWARTZ |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/05/1986 |
Decision Date | 04/01/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|