The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Smart-well Incubator.
| Device ID | K122362 |
| 510k Number | K122362 |
| Device Name: | SMART-WELL INCUBATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | MESA LABORATORIES, INC. 12100 W. 6TH AVENUE Lakewood, CO 80228 |
| Contact | Jole Wilson |
| Correspondent | Jole Wilson MESA LABORATORIES, INC. 12100 W. 6TH AVENUE Lakewood, CO 80228 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2013-03-26 |