FDA.reportPublic FDA data

510(k) K212022

Device
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Applicant
3M Company
510(k) number
K212022
Product code
QKM  
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-20
Date received
2021-06-29
Regulation
880.2800
Classification name
A Chemical Vapor Sterilization Multivariable Chemical Indicator
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mary Fretland
Address
3m Center, Bldg. 275-5w-06 St. Paul MN US 55144 55144

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QKM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)Terragene S.A.2024-04-05
K213262CELERITY HP Chemical IndicatorSTERIS Corporation2022-01-07
K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company2020-12-07
K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Healthcare2020-03-13

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases