The following data is part of a premarket notification filed by Norav Medical Ltd. with the FDA for Pc Ecg 1200.
| Device ID | K000404 |
| 510k Number | K000404 |
| Device Name: | PC ECG 1200 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110252519 | K000404 | 000 |
| 18052400180263 | K000404 | 000 |
| 07290110252502 | K000404 | 000 |