SMART-WELL INCUBATOR


Device Classification Name

indicator, biological sterilization process

510(k) Number K122362
Device Name SMART-WELL INCUBATOR
Applicant
MESA LABORATORIES, INC.
12100 w. 6th avenue
lakewood, 
CO 
80228

Applicant Contact jole wilson
Correspondent
MESA LABORATORIES, INC.
12100 w. 6th avenue
lakewood, 
CO 
80228

Correspodent Contact jole wilson
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 08/06/2012
Decision Date 03/26/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No