The following data is part of a premarket notification filed by Dideco with the FDA for Data Master Perfusion Monitoring System.
| Device ID | K001388 |
| 510k Number | K001388 |
| Device Name: | DATA MASTER PERFUSION MONITORING SYSTEM |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | DIDECO 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson DIDECO 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-02 |
| Decision Date | 2000-07-28 |