The following data is part of a premarket notification filed by Intl. Business Machines with the FDA for Ibm 5885 Digital Ecg Acquisition Cart.
| Device ID | K810988 |
| 510k Number | K810988 |
| Device Name: | IBM 5885 DIGITAL ECG ACQUISITION CART |
| Classification | Electrocardiograph |
| Applicant | INTL. BUSINESS MACHINES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-13 |
| Decision Date | 1981-05-01 |