BioButton System
FDA 510(k) K241101 · Biointellisense, Inc.
510(k) numberK241101
Submission
- Device name
- BioButton System
- Applicant
- Biointellisense, Inc.
Redwood City, CA, US - Received
- April 22, 2024
- Decision date
- September 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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Questions and answers
When was BioButton System cleared by the FDA?
BioButton System (K241101) received a 510(k) decision of Substantially Equivalent on September 26, 2024, 157 days after the submission was received.
What is the product code of K241101?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.