The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd with the FDA for E-cube Inno.
| Device ID | K121937 |
| 510k Number | K121937 |
| Device Name: | E-CUBE INNO |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALPINION MEDICAL SYSTEMS CO., LTD 1, 6 AND 7FL, VERDI TOWER 72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU Seoul, KR 152-848 |
| Contact | Donghwan Kim |
| Correspondent | Donghwan Kim ALPINION MEDICAL SYSTEMS CO., LTD 1, 6 AND 7FL, VERDI TOWER 72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU Seoul, KR 152-848 |
| 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 | 2012-07-02 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800013527004 | K121937 | 000 |
| 08800013512024 | K121937 | 000 |
| 08800013511034 | K121937 | 000 |
| 08800013510082 | K121937 | 000 |
| 08800013510051 | K121937 | 000 |
| 08800013510044 | K121937 | 000 |