The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Vitropro.
| Device ID | K222052 |
| 510k Number | K222052 |
| Device Name: | VitroPRO |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO Medical Instruments Co., Inc. 102 First Street South Kalona, IA 52247 |
| Contact | Jim Leong |
| Correspondent | Jim Leong CIVCO Medical Instruments Co., Inc. 102 First Street South Kalona, IA 52247 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-12 |
| Decision Date | 2022-11-22 |