Data / Medical devices / United States / B'orze Inc
B'orze Inc: FDA-registered device maker in Boise, ID, United States, 2 510(k) clearances
B'orze Inc is registered with the FDA (registration 3010395077) in Boise, ID, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 1, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010395077
- Address
- 950 W Bannock Suite 100, Boise, ID, United States, 83702
- Owner or operator
- B'Orze Inc USA (10046152)
- Roles
- Specification developer
- First device listed
- August 29, 2020
- Registered through
- 2026
- Brand names listed
- B`ORZE FETAL MONITOR WL 15000 MODEL NO BZ - WL - 015 - 01, B`ORZE INC DIGITAL VIDEO COLPOSCOPE HD INTTELLIO MODEL NO BZ-HD1-001, B`ORZE INC USA FETAL MONITOR FM 700
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | 2 | Specification developer | accessdata.fda.gov |
| Monitor, Ultrasonic, Fetal | KNG | 2 | Specification developer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Obstetric | HGL | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 1, 2019 | K182710 | Fetal Doppler, Model FD88 | KNG | Substantially Equivalent | Shenzzhen Luckcome Technology Inc., Ltd. | accessdata.fda.gov |
| March 21, 2013 | K123335 | SUNRAY FETAL MONITOR | HGM | Substantially Equivalent | Sunray Medical Apparatus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Colposcope (And Colpomicroscope)
- All makers of System, Monitoring, Perinatal
- All makers of Transducer, Ultrasonic, Obstetric
- All makers of Monitor, Ultrasonic, Fetal
Updated March 1, 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.