The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd with the FDA for E-cube 7.
| Device ID | K132687 |
| 510k Number | K132687 |
| Device Name: | E-CUBE 7 |
| 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 | 2013-08-28 |
| Decision Date | 2013-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800013510037 | K132687 | 000 |
| 08800013510105 | K132687 | 000 |
| 08800013511003 | K132687 | 000 |
| 08800013511010 | K132687 | 000 |
| 08800013512000 | K132687 | 000 |
| 08800013513007 | K132687 | 000 |
| 08800013513014 | K132687 | 000 |
| 08800013513038 | K132687 | 000 |
| 08800013513045 | K132687 | 000 |
| 08800013514011 | K132687 | 000 |
| 08800013521002 | K132687 | 000 |
| 08800013510006 | K132687 | 000 |