The following data is part of a premarket notification filed by Intl. Business Machines with the FDA for Ibm 2991 Blood Cell Processor Mod. 1 & 2.
| Device ID | K812355 |
| 510k Number | K812355 |
| Device Name: | IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 |
| Classification | Apparatus, Autotransfusion |
| Applicant | INTL. BUSINESS MACHINES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-19 |
| Decision Date | 1981-09-09 |