K122362 is an FDA 510(k) clearance for the SMART-WELL INCUBATOR. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Mesa Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 26, 2013, 232 days after receiving the submission on August 6, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K122362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2012 |
| Decision Date | March 26, 2013 |
| Days to Decision | 232 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRC - Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |