Device Listing 1041606167
Listing Summary
- Listing key
- 1041606167
- Premarket submission
- K253269
- Device
- OEC One CFD
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
- Product code
- OXO
- Decision date
- 2025-11-26
Related Registrations
| Registration key | Registration | FEI | Company | Status | Initial importer | Expiration | Address |
|---|---|---|---|---|---|---|---|
| 26611 | 9613445 | 3002175190 | Tracey Holevas | 1 | N | 2026-01-01 | 3000 N. Grandview BLVD Waukesha WI US 53188 |
| 199689 | 3008284470 | 3008284470 | GE Healthcare (China) Co., Ltd. | 1 | N | 2026-01-01 | 1F-5F BLD 1, No.1 Tongji South Road Beijing Economic-Technological Development Area Beijing CN 100176 |