Minisono
System, Imaging, Pulsed Doppler, Ultrasonic
Alpinion Medical Systems Co., Ltd.
The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd. with the FDA for Minisono.
Pre-market Notification Details
| Device ID | K182845 |
| 510k Number | K182845 |
| Device Name: | Minisono |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Alpinion Medical Systems Co., Ltd. 5fl, I Dong, 77, Heungan-daero 81 Beon-gil Dongan-gu Anyang-si, KR 14117 |
| Contact | Boyeon Cho |
| Correspondent | Boyeon Cho Alpinion Medical Systems Co., Ltd. 5fl, I Dong, 77, Heungan-daero 81 Beon-gil Dongan-gu Anyang-si, KR 14117 |
| 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 | 2018-10-09 |
| Decision Date | 2018-12-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800013531001 | K182845 | 000 |
| 08800013530004 | K182845 | 000 |
Trademark Results [Minisono]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINISONO 87728861 not registered Live/Pending |
ALPINION MEDICAL SYSTEMS CO., LTD. 2017-12-20 |
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