Data / Medical devices / India / Blue Cloud Softech Solutions Ltd
Blue Cloud Softech Solutions Ltd: FDA-registered device maker in Hyderabad Telangana, India, 1 510(k) clearance
Blue Cloud Softech Solutions Ltd is registered with the FDA (registration 3017840920) in Hyderabad Telangana, India. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017840920
- Address
- Plot No 38, 5th Floor, Software Units Layout HITEC City Madhapur, Hyderabad Telangana, India, 500081
- Owner or operator
- Blue Cloud Softech Solutions Limited (10078832)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 6, 2020
- Registered through
- 2026
- Brand names listed
- Air Sanitizer, BluHealth Screener App, BluHealth Scanner Device - BluHealth Platform ECG, Temp Scanner device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antimicrobial Keyboard | OSZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | QME | 2 | 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 |
|---|---|---|---|---|---|---|
| September 1, 2023 | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | QME | Substantially Equivalent | Faceheart Corp. | accessdata.fda.gov |
Compare with other makers
Updated September 1, 2023. 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.