The following data is part of a premarket notification filed by Diagnostic Monitoring Software with the FDA for Holter 24-hour Ecg System, Model Number: Dms 300.
| Device ID | K911615 |
| 510k Number | K911615 |
| Device Name: | HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | DIAGNOSTIC MONITORING SOFTWARE 17300 SEVENTEENTH ST. J-344 Tustin, CA 92680 |
| Contact | Jerry Fails |
| Correspondent | Jerry Fails DIAGNOSTIC MONITORING SOFTWARE 17300 SEVENTEENTH ST. J-344 Tustin, CA 92680 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1992-01-08 |