Device |
a chemical vapor sterilization multivariable chemical indicator |
Regulation Description |
Sterilization process indicator. |
Definition |
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process. |
Physical State |
The device consists of chemicals attached to a non-reactive material surface that react to two or sterilization process parameters. |
Technical Method |
Uses chemical reactions to indicate a pass signal to sterilization parameters that are consistent with identified stated values |
Target Area |
not intended for patient contact |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | QKM |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
Submission Type |
510(k)
|
Regulation Number |
880.2800
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |