The following data is part of a premarket notification filed by Inbody Co, Ltd. with the FDA for Inbody Blood Pressure Monitor, Model Bpbio480kv.
| Device ID | K221764 |
| 510k Number | K221764 |
| Device Name: | InBody Blood Pressure Monitor, Model BPBIO480KV |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | InBody Co, Ltd. 15, Heugam-Gil , Ipjang-Myueon, Seoubuk-Gu Cheonan-Si, KR 31025 |
| Contact | Kichul Cha |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-17 |
| Decision Date | 2022-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809930290022 | K221764 | 000 |