Data / Medical devices / India / Turtle Shell Technologies Private Limited
Turtle Shell Technologies Private Limited: FDA-registered device maker in Bengaluru Karnataka, India, 1 510(k) clearance
Turtle Shell Technologies Private Limited is registered with the FDA (registration 3030284974) in Bengaluru Karnataka, India. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030284974
- Address
- #40,City Center, Ground and Mezzanine Floor, CMH Road, Indiranagar, Bengaluru Karnataka, India, 560038
- Owner or operator
- Turtle Shell Technologies Private Limited (10090062)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 9, 2024
- Registered through
- 2026
- Brand names listed
- Dozee Home, Dozee SE, Dozee VS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 15, 2022 | K221555 | Dozee VS | BZQ | Substantially Equivalent | Turtle Shell Technologies Private Limited | accessdata.fda.gov |
Compare with other makers
Updated December 15, 2022. 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.