The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Civ-clear Cover.
| Device ID | K211270 |
| 510k Number | K211270 |
| Device Name: | CIV-Clear Cover |
| 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 | 2021-04-27 |
| Decision Date | 2021-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436120326 | K211270 | 000 |
| 00841436120319 | K211270 | 000 |
| 00841436120302 | K211270 | 000 |
| 00841436120296 | K211270 | 000 |
| 00841436120289 | K211270 | 000 |
| 00841436120272 | K211270 | 000 |
| 00841436120265 | K211270 | 000 |
| 80841436121244 | K211270 | 000 |