Data / Medical devices / United States / Biointellisense Inc.
Biointellisense Inc.: FDA-registered device maker in Golden, CO, United States, 3 510(k) clearances
Biointellisense Inc. is registered with the FDA (registration 3017986070) in Golden, CO, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017986070
- Address
- 611 Corporate Cir Ste E-H, Golden, CO, United States, 80401
- Owner or operator
- BioIntelliSense Inc. (10062701)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 3, 2020
- Registered through
- 2026
- Brand names listed
- BioButton Adhesive V2, Cold Seal (ADH-CS), BioButton Adhesives v1 (2x5pcs and 50x5pcs, OMI, ADB, ACCS-1-ST06-1-4F), BioButton Adhesives v2 (2x5pcs and 50x5pcs, HT, ADD, ADH-AC1-BBR), BioButton Charging Station, BioButton MPU, BioButton Rechargeable, BioButton Rechargeable (BBR), BioButton System (Multi-patient Use or MPU) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 26, 2024 | K241101 | BioButton System | DRG | Substantially Equivalent | Biointellisense, Inc. | accessdata.fda.gov |
| December 12, 2022 | K212957 | BioButton System | DRG | Substantially Equivalent | Biolntellisense, Inc. | accessdata.fda.gov |
| December 18, 2019 | K191614 | BioSticker System | DRG | Substantially Equivalent | Biointellisense, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Calculator, Drug Dose
- All makers of Tape And Bandage, Adhesive
Updated September 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.