The following data is part of a premarket notification filed by Orantech Inc. with the FDA for Patient Cables And Leadwires , Disposable Ecg Leadwires.
| Device ID | K182327 |
| 510k Number | K182327 |
| Device Name: | Patient Cables And Leadwires , Disposable ECG Leadwires |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Orantech Inc. Zone#A, 4F, 1st Bld, 7th Industrial Zone Yulv Community, GongMing Shenzhen, CN 518106 |
| Contact | Hsin Xiong |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O BOX 120-119 Shanghai, CN 200120 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2019-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970706361658 | K182327 | 000 |
| 06941691975335 | K182327 | 000 |
| 06941691975328 | K182327 | 000 |
| 06941691975311 | K182327 | 000 |
| 06941691975304 | K182327 | 000 |
| 06941691975298 | K182327 | 000 |
| 06941691975281 | K182327 | 000 |
| 06941691975274 | K182327 | 000 |
| 06941691975267 | K182327 | 000 |
| 06941691975250 | K182327 | 000 |
| 06941691975243 | K182327 | 000 |
| 06941691924050 | K182327 | 000 |
| 06941691924357 | K182327 | 000 |
| 06941691924555 | K182327 | 000 |
| 06970706360774 | K182327 | 000 |
| 06941691940074 | K182327 | 000 |
| 06941691940012 | K182327 | 000 |
| 06941691938194 | K182327 | 000 |
| 06941691936374 | K182327 | 000 |
| 06941691934196 | K182327 | 000 |
| 06941691931850 | K182327 | 000 |
| 06941691931812 | K182327 | 000 |
| 06941691931614 | K182327 | 000 |
| 06941691924586 | K182327 | 000 |
| 06941691974604 | K182327 | 000 |