K231531
- 510(k) number
- K231531
- Device name
- Pediarity
- Applicant
- Hinlab, Inc. DE · US
- Product code
- DQA — Oximeter
- Decision date
- 2023-12-21
- Date received
- 2023-05-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K231531.pdf
Official FDA record: K231531
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.