The following data is part of a premarket notification filed by Norav Medical Corp. with the FDA for Nh-301 Ambulatory Ecg Analysis Software.
| Device ID | K111487 |
| 510k Number | K111487 |
| Device Name: | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | NORAV MEDICAL CORP. INDUSTRIAL PARK 13, M.P. MISGAV Mitzpe Aviv, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy NORAV MEDICAL CORP. INDUSTRIAL PARK 13, M.P. MISGAV Mitzpe Aviv, IL 20187 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-31 |
| Decision Date | 2011-11-10 |
| Summary: | summary |