The following data is part of a premarket notification filed by Auckland Medical Polymer(tianjin) Co., Ltd. with the FDA for Okland Patient Return Electrode Pad.
| Device ID | K183148 |
| 510k Number | K183148 |
| Device Name: | OKLand Patient Return Electrode Pad |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Auckland Medical Polymer(Tianjin) Co., Ltd. Building D5-2, XEDA International Industrial Park Tianjin, CN 300385 |
| Contact | Bei Lei Gao |
| Correspondent | Bei Lei Gao Auckland Medical Polymer(Tianjin) Co., Ltd. Building D5-2, XEDA International Industrial Park Tianjin, CN 300385 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2020-02-04 |