The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Cpi Printer.
| Device ID | K822857 |
| 510k Number | K822857 |
| Device Name: | CPI PRINTER |
| Classification | Holder, Speculum, Ent |
| Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KAG |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-27 |
| Decision Date | 1983-01-08 |