The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Stockert Power Supply Unit For S3 Components.
| Device ID | K990512 |
| 510k Number | K990512 |
| Device Name: | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia Jm Nolte |
| Correspondent | Cynthia Jm Nolte STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 1999-11-23 |