← FDA Medical Device Classifications
A Chemical Vapor Sterilization Multivariable Chemical Indicator
QKM · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2800
Classification
- FDA Product Code
QKM- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 880.2800
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Market data
- Cleared 510(k) submissions
- 5
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown