| Device Classification Name |
monitor, blood-gas, on-line, cardiopulmonary bypass |
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|---|---|---|---|---|
| 510(k) Number | K110957 | |||
| Device Name | M4 MONITOR | |||
| Applicant |
|
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| Applicant Contact | steve turner | |||
| Regulation Number | 870.4330 | |||
| Classification Product Code |
|
|||
| Date Received | 04/05/2011 | |||
| Decision Date | 05/31/2011 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Cardiovascular |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |