The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Betatron Ii.
| Device ID | K823204 |
| 510k Number | K823204 |
| Device Name: | BETATRON II |
| Classification | Pump, Infusion |
| Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-27 |
| Decision Date | 1982-11-30 |