K242860

Type 5 Integrating Indicator for Steam (CSPN-15)

510(k) number
K242860
Device name
Type 5 Integrating Indicator for Steam (CSPN-15)
Applicant
True Indicating, LLC OH · US
Product code
JOJ — Indicator, Physical/Chemical Sterilization Process
Decision date
2025-01-17
Date received
2024-09-20
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General Hospital
510(k) Summary (official FDA PDF): K242860.pdf
Official FDA record: K242860
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.