The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd. with the FDA for E-cube I7.
| Device ID | K153424 |
| 510k Number | K153424 |
| Device Name: | E-CUBE I7 |
| 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 | 2015-11-25 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800013513083 | K153424 | 000 |
| 08800013513076 | K153424 | 000 |
| 08800013526007 | K153424 | 000 |
| 08800013512079 | K153424 | 000 |
| 08800013512062 | K153424 | 000 |
| 08800013511102 | K153424 | 000 |
| 08800013511072 | K153424 | 000 |
| 08800013510143 | K153424 | 000 |
| 08800013510129 | K153424 | 000 |