Data / Medical devices / United States / Wesper Inc. Lic
Wesper Inc. Lic: FDA-registered device maker in Long Island City, NY, United States, 3 510(k) clearances
Wesper Inc. Lic is registered with the FDA (registration 3024722701) in Long Island City, NY, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 9, 2023. Registered through 2026. FDA data exported November 2, 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
- 3024722701
- Address
- 44-02 11th St. Ste 610, Long Island City, NY, United States, 11101
- Owner or operator
- Wesper Inc. (10085957)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 22, 2022
- Registered through
- 2026
- Brand names listed
- Oxiband (Checkme) O2 Pulse Oximeter, Wesper Lab
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 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 |
|---|---|---|---|---|---|---|
| March 9, 2023 | K221816 | Wesper Lab | MNR | Substantially Equivalent | Wesper, Inc. | accessdata.fda.gov |
| December 21, 2021 | K203343 | Wesper Lab | MNR | Substantially Equivalent | Wesper, Inc. | accessdata.fda.gov |
| December 2, 2019 | K191088 | Checkme O2 Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilatory Effort Recorder
- All makers of Monitor, Breathing Frequency
- All makers of Oximeter
Updated March 9, 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.