BioButton System— 510(k) K241101
Substantially EquivalentBiointellisense, Inc.
FDA 510(k) clearance K241101 for BioButton System, Substantially Equivalent on 2024-09-26. Applicant: Biointellisense, Inc.. Device class: 2.
Clearance details
- Applicant
- Biointellisense, Inc.
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code DRG
view allMore clearances from Biointellisense, Inc.
view allAdverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.