The following data is part of a premarket notification filed by Integral Process Sas with the FDA for Ecg Multi Leads And Ip-set Trunk Cable, Monobloc Ecg Cable, Spo2 Sensors And Ibp Transducers Interface Cable, Ecg Leadwire For Integral Process Trunk Cables, Ecg Leadwire For Original Truk Cables.
| Device ID | K162768 |
| 510k Number | K162768 |
| Device Name: | ECG Multi Leads And IP-SET Trunk Cable, Monobloc ECG Cable, SpO2 Sensors And IBP Transducers Interface Cable, ECG Leadwire For INTEGRAL PROCESS Trunk Cables, ECG Leadwire For Original Truk Cables |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | INTEGRAL PROCESS SAS 12 RUE DES CAYENNES PO BOX BP 20310 Conflans Sainte Honorine, FR 78703 |
| Contact | Virginie S Grondin |
| Correspondent | Virginie S Grondin INTEGRAL PROCESS SAS 12 RUE DES CAYENNES PO BOX BP 20310 Conflans Sainte Honorine, FR 78703 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700506312511 | K162768 | 000 |
| 03700506312924 | K162768 | 000 |
| 03700506311422 | K162768 | 000 |
| 03700506304813 | K162768 | 000 |
| 03700506304790 | K162768 | 000 |
| 03700506304349 | K162768 | 000 |
| 03700506303809 | K162768 | 000 |
| 03700506303700 | K162768 | 000 |
| 03700506303625 | K162768 | 000 |
| 03700506303601 | K162768 | 000 |
| 03700506320196 | K162768 | 000 |
| 03700506320189 | K162768 | 000 |
| 03700506319466 | K162768 | 000 |
| 03700506319046 | K162768 | 000 |
| 03700506318902 | K162768 | 000 |
| 03700506318919 | K162768 | 000 |
| 03700506319176 | K162768 | 000 |
| 03700506311484 | K162768 | 000 |
| 03700506309160 | K162768 | 000 |
| 03700506304370 | K162768 | 000 |
| 03700506304004 | K162768 | 000 |
| 03700506317318 | K162768 | 000 |
| 03700506317882 | K162768 | 000 |
| 03700506303151 | K162768 | 000 |
| 03700506304066 | K162768 | 000 |
| 03700506303953 | K162768 | 000 |
| 03700506319411 | K162768 | 000 |
| 03700506319251 | K162768 | 000 |
| 03700506300433 | K162768 | 000 |
| 03700506319459 | K162768 | 000 |
| 03700506304653 | K162768 | 000 |