The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd. with the FDA for E-cube 11.
| Device ID | K161439 |
| 510k Number | K161439 |
| Device Name: | E-CUBE 11 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALPINION MEDICAL SYSTEMS CO., LTD. 1FL AND 6FL VERDI TOWER, 72, DIGITAL-RO(ST) 26-GIL(RD), GURO-GU Seoul, KR 08393 |
| Contact | Donghwan Kim |
| Correspondent | Donghwan Kim ALPINION MEDICAL SYSTEMS CO., LTD. 1FL AND 6FL VERDI TOWER, 72, DIGITAL-RO(ST) 26-GIL(RD), GURO-GU Seoul, KR 08393 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-24 |
| Decision Date | 2016-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800013523006 | K161439 | 000 |