The following data is part of a premarket notification filed by Norav Medical Ltd. with the FDA for Pcecg-1200 System With Modular Ecg Analysis System (means).
| Device ID | K110463 |
| 510k Number | K110463 |
| Device Name: | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | NORAV MEDICAL LTD. INDUSTRIAL PARK 13 M.P. MISGAV Mitzpe Aviv, IL 20187 |
| Contact | Benry Arazy |
| Correspondent | Benry Arazy NORAV MEDICAL LTD. INDUSTRIAL PARK 13 M.P. MISGAV Mitzpe Aviv, IL 20187 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-17 |
| Decision Date | 2011-11-10 |
| Summary: | summary |