K233413
- 510(k) number
- K233413
- Device name
- Ultraphon Chemical Indicator (TRO-T and TRO-B)
- Applicant
- True Indicating, LLC OH · US
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2024-06-26
- Date received
- 2023-10-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233413.pdf
Official FDA record: K233413
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.