Data / Medical devices / United States / Pivot Health Technologies Inc
Pivot Health Technologies Inc: FDA-registered device maker in San Carlos, CA, United States, 1 510(k) clearance
Pivot Health Technologies Inc is registered with the FDA (registration 3014023337) in San Carlos, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014023337
- Address
- 1010 Commercial Street Suite C, San Carlos, CA, United States, 94070
- Owner or operator
- Pivot Health Technologies Inc. (10055866)
- Roles
- Specification developer
- First device listed
- October 13, 2017
- Registered through
- 2026
- Brand names listed
- Pivot Breath Sensor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | CCJ | 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 |
|---|---|---|---|---|---|---|
| September 29, 2017 | K171408 | Carbon Monoxide Breath Sensor System (COBSS) | CCJ | Substantially Equivalent | Carrot Sense, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 29, 2017. 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.