The following data is part of a premarket notification filed by Dart Medical Equipment with the FDA for Criterion Ii Rhythm Profile Monitor.
| Device ID | K803315 |
| 510k Number | K803315 |
| Device Name: | CRITERION II RHYTHM PROFILE MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | DART MEDICAL EQUIPMENT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-01-22 |