The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gm85.
Device ID | K222353 |
510k Number | K222353 |
Device Name: | GM85 |
Classification | System, X-ray, Mobile |
Applicant | Samsung Electronics Co., LTD. 129, Samsung-Ro, Yeongtong-Gu Suwon-Si, KR 16677 |
Contact | Jaesang Noh |
Correspondent | Jaesang Noh Samsung Electronics Co., LTD. 129, Samsung-Ro, Yeongtong-Gu Suwon-Si, KR 16677 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-08-04 |
Decision Date | 2022-09-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08806094744934 | K222353 | 000 |