The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for S3 Cardioplegia Control Module Version 2.0.
| Device ID | K002116 |
| 510k Number | K002116 |
| Device Name: | S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-13 |
| Decision Date | 2000-08-09 |