510(k) DEN210004
- Device
- Zuno Smart Sterilization Container
- Applicant
- Zuno Medical, Inc.
- 510(k) number
- DEN210004
- Product code
- QJT
- Decision
- Unknown (DENG)
- Decision date
- 2022-06-17
- Date received
- 2021-02-16
- Regulation
- 880.6855
- Classification name
- Rigid Sterilization Container With Software
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Allan McNichol
- Address
- 743 Camden Ave., Suite B Campbell CA US 95008 95008
Source Documents
510(k) summary PDF not indicated by FDA