Product code QKM
- Device name
- A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2800
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
- Source
- FDA openFDA device classification dataset