The following data is part of a premarket notification filed by Dart Medical Equipment with the FDA for Criterion Ii Pacing System Monitors.
| Device ID | K800286 |
| 510k Number | K800286 |
| Device Name: | CRITERION II PACING SYSTEM MONITORS |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | DART MEDICAL EQUIPMENT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-08 |
| Decision Date | 1980-03-12 |