K233965
- 510(k) number
- K233965
- Device name
- UltraDrape UGPIV Barrier and Securement (34-15)
- Applicant
- Parker Laboratories, Inc. NJ · US
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2024-08-15
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233965.pdf
Official FDA record: K233965
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.