510(k) K212957
K212957 is an FDA 510(k) premarket notification submitted by Biolntellisense, Inc. for the device "BioButton System". The FDA issued a decision of Substantially Equivalent on December 12, 2022. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2022
- Date Received
- September 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type