SMART-WELL INCUBATOR
FDA 510(k) clearance K122362 · decided 2013-03-26
Clearance details
- K-number
- K122362
- Device name
- SMART-WELL INCUBATOR
- Applicant
- Mesa Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-06
- Decision date
- 2013-03-26
- Days to decision
- 232 days
- Clearance type
- Special
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.