The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hm70 Evo Diagnostic Ultrasound System.
Device ID | K220269 |
510k Number | K220269 |
Device Name: | HM70 EVO Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, KP 25108 |
Contact | Ju Jee Young |
Correspondent | Jee Young Ju Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, KP 25108 |
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 | 2022-01-31 |
Decision Date | 2022-05-06 |