The following data is part of a premarket notification filed by Norav Medical Gmbh with the FDA for Nr Recorder.
| Device ID | K161062 |
| 510k Number | K161062 |
| Device Name: | NR Recorder |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | Norav Medical GmbH Otto Von Guericke Ring 10 Wiesbaden, DE 65205 |
| Contact | David Seal |
| Correspondent | Raymond Kelly Licensale Inc 57 Lazy Brook Rd Monroe, CT 06468 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-06-13 |