SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
FDA 510(k) clearance DEN110002 · decided 2012-03-30
Clearance details
- K-number
- DEN110002
- Device name
- SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
- Applicant
- STERIS Corporation
- Decision
- Unknown
- Date received
- 2011-08-01
- Decision date
- 2012-03-30
- Days to decision
- 242 days
- Clearance type
- Post-NSE
- Product code
- OVY
- Device class
- 2
- Regulation number
- 880.6887
- 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.