Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K242189

CELERITY HP Indicator Tape (PCC077)

510(k) number
K242189
Device name
CELERITY HP Indicator Tape (PCC077)
Applicant
Steris OH · US
Product code
JOJ — Indicator, Physical/Chemical Sterilization Process
Decision date
2024-08-20
Date received
2024-07-25
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
General Hospital
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K242189.pdf

Official FDA record: K242189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.