K241803
- 510(k) number
- K241803
- Device name
- INSULCLOCK® v2.0 PRO
- Applicant
- Insulcloud S.L. ES
- Product code
- QOG — Injection Data Capture Device
- Decision date
- 2024-08-22
- Date received
- 2024-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241803.pdf
Official FDA record: K241803
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.