The following data is part of a premarket notification filed by Intl. Business Machines with the FDA for Ibm 588 Digital Ecg Acquisition/analysis.
| Device ID | K830163 |
| 510k Number | K830163 |
| Device Name: | IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | INTL. BUSINESS MACHINES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-02-18 |