VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
FDA 510(k) clearance K213412 · decided 2022-01-21
Clearance details
- K-number
- K213412
- Device name
- VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
- Applicant
- Steris Corparation
- Decision
- Substantially Equivalent
- Date received
- 2021-10-19
- Decision date
- 2022-01-21
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.