Data / Medical devices / United States / Digicare Biomedical Technology, Inc.
Digicare Biomedical Technology, Inc.: FDA-registered device maker in Boynton Beach, FL, United States, 1 510(k) clearance
Digicare Biomedical Technology, Inc. is registered with the FDA (registration 1062836) in Boynton Beach, FL, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1062836
- FEI number
- 3000718682
- Address
- 107 Commerce RD., Boynton Beach, FL, United States, 33426
- Owner or operator
- DIGICARE BIOMEDICAL TECHNOLOGY, INC. (9029705)
- Roles
- Manufacturer
- First device listed
- September 26, 2019
- Registered through
- 2026
- Brand names listed
- LifeWindow LW8 Lite Multi-Parameter Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | 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 25, 2019 | K183687 | LifeWindow LW8 Lite | MWI | Substantially Equivalent | Digicare Biomedical Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Gas, Oxygen, Gaseous-Phase
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Computer, Blood-Pressure
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Updated September 25, 2019. 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.