Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017986070

FEI Number

3017986070

Entity Name

BIOINTELLISENSE INC.

City/State/Country

Golden, CO, US

Establishment Address

17301 W. Colfax Ave., Suite 152, Golden, CO 80401, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

BioIntelliSense Inc. (Owner Number: 10062701)

Owner / Operator Contact Address

805 Veterans Blvd, UNIT 105, Redwood City, CA 94063, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241101

PMA Number

N/A

All Registered Proprietary Names

BioButton BioButton wearable device BioButton remote patient monitoring device BioButton wearable sensor BioSticker BioSticker wearable sensor BioSticker on-body sensor BioSticker wearable device BioSticker remote patient monitoring device BioButton Charging Station BioButton System (Multi-patient Use or MPU) BioButton MPU BioButton v3 BioButton Rechargeable (BBR) BioButton Rechargeable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-12-14
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2022-12-14
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2020-03-03
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2020-03-03
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-09-30
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2024-09-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioIntelliSense Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016592682	BIOINTELLISENSE INC.	Redwood City, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K832250	Litton Medical Electronics	SERVOMED BASIC BEDSIDE UNIT SMA 102-	1984-06-01
K801515	Abbott Medical Electronics Co.	ABBY II PATIENT MONITOR OR VITAL SIGNS M	1980-07-08

Similar Registrations

Registration Number	Establishment Name	Location
3033118181	CHERO TECHNOLOGY CO., LTD.	Jiaxing Zhejiang, CN
3026960443	Cicor Medtec Bucharest	Bucharest Bucuresti, RO
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB
3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017986070. Last updated year: 2026. Please use registration number 3017986070 when referencing this establishment in official correspondence.