The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Ex3 Stepper, Classic Stepper, Multi-purpose Workstation Stepper; Micro-touch, Micro-touch Lp, Mulit-purpose Workstation,.
| Device ID | K131161 |
| 510k Number | K131161 |
| Device Name: | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Contact | Amanda Stahle |
| Correspondent | Amanda Stahle CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Product Code | ITX |
| Subsequent Product Code | IWJ |
| Subsequent Product Code | JAQ |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-24 |
| Decision Date | 2013-09-17 |
| Summary: | summary |