The following data is part of a premarket notification filed by Diagnostic Monitoring Software with the FDA for Premier 11 Holter.
| Device ID | K062088 |
| 510k Number | K062088 |
| Device Name: | PREMIER 11 HOLTER |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | DIAGNOSTIC MONITORING SOFTWARE 292 KINGSBURY GRADE, #32 P.O. BOX 3109 Stateline, NV 89449 |
| Contact | William Parsons |
| Correspondent | William Parsons DIAGNOSTIC MONITORING SOFTWARE 292 KINGSBURY GRADE, #32 P.O. BOX 3109 Stateline, NV 89449 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-08-25 |
| Summary: | summary |