The following data is part of a premarket notification filed by Norav Medical Ltd. with the FDA for Pc Ecg 1200w System.
| Device ID | K080141 |
| 510k Number | K080141 |
| Device Name: | PC ECG 1200W SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | NORAV MEDICAL LTD. INDUSTRIAL PARK 13 M.P. MISGAV Mitzpe Aviv, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny 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 | 2008-01-22 |
| Decision Date | 2008-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180287 | K080141 | 000 |