510(k) K211585
K211585 is an FDA 510(k) premarket notification submitted by Bodyport, Inc. for the device "Bodyport Cardiac Scale". The FDA issued a decision of Substantially Equivalent on July 29, 2022. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2022
- Date Received
- May 24, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type