The following data is part of a premarket notification filed by Bib, Inc. with the FDA for Pace-pulse/computrac.
| Device ID | K800782 |
| 510k Number | K800782 |
| Device Name: | PACE-PULSE/COMPUTRAC |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | BIB, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-08 |
| Decision Date | 1980-05-28 |