The following data is part of a premarket notification filed by Norav Medical Ltd. with the FDA for Norav Holter System, Model Nh-300 V1.07.
| Device ID | K012712 |
| 510k Number | K012712 |
| Device Name: | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | NORAV MEDICAL LTD. 12505 58TH AVE. N. Plymouth, MN 55442 |
| Contact | Steve Springrose |
| Correspondent | Steve Springrose NORAV MEDICAL LTD. 12505 58TH AVE. N. Plymouth, MN 55442 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2002-05-08 |