The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gm60a-32s & Gm60a-40s.
| Device ID | K150097 |
| 510k Number | K150097 |
| Device Name: | GM60A-32S & GM60A-40S |
| Classification | System, X-ray, Mobile |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, KR 443742 |
| Contact | Chulsin Kim |
| Correspondent | Chulsin Kim SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, KR 443742 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806086571210 | K150097 | 000 |