K241036
- 510(k) number
- K241036
- Device name
- Autoclave Indicator Tape; EO Indicator Tape
- Applicant
- Jiangmen New Era External Use Drug Co., Ltd. CN
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2024-12-17
- Date received
- 2024-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241036.pdf
Official FDA record: K241036
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.