The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Infant Phototherapy Equipment.
| Device ID | K210289 |
| 510k Number | K210289 |
| Device Name: | Infant Phototherapy Equipment |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | Bistos Co., Ltd. 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam-si, KR 13201 |
| Contact | Dae Eun Kim |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-02-02 |
| Decision Date | 2021-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800012345002 | K210289 | 000 |
| 18800012345019 | K210289 | 000 |