The following data is part of a premarket notification filed by Bodyport Inc. with the FDA for Bodyport Cardiac Scale.
| Device ID | K211585 |
| 510k Number | K211585 |
| Device Name: | Bodyport Cardiac Scale |
| Classification | Plethysmograph, Impedance |
| Applicant | Bodyport Inc. 970 Folsom Street San Francisco, CA 94107 |
| Contact | Mara Korsunsky |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2022-07-29 |