The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Interface Module Iddd.
| Device ID | K992635 |
| 510k Number | K992635 |
| Device Name: | INTERFACE MODULE IDDD |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 1999-12-20 |
| Summary: | summary |