The following data is part of a premarket notification filed by Civco Medical Solutions with the FDA for Envision Ultrasound Pad And Cover.
| Device ID | K190802 |
| 510k Number | K190802 |
| Device Name: | Envision Ultrasound Pad And Cover |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO Medical Solutions 102 First St. South Kalona, IA 52247 |
| Contact | Jim Leong |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436115025 | K190802 | 000 |
| 00841436125086 | K190802 | 000 |
| 00841436125079 | K190802 | 000 |
| 00841436124263 | K190802 | 000 |
| 00841436124256 | K190802 | 000 |
| 00841436124249 | K190802 | 000 |
| 00841436124232 | K190802 | 000 |
| 00841436124225 | K190802 | 000 |
| 00841436124218 | K190802 | 000 |
| 00841436124201 | K190802 | 000 |
| 00841436124195 | K190802 | 000 |
| 00841436124188 | K190802 | 000 |
| 00841436124171 | K190802 | 000 |
| 00841436124164 | K190802 | 000 |
| 00841436122030 | K190802 | 000 |
| 00841436122023 | K190802 | 000 |
| 80841436114963 | K190802 | 000 |
| 00841436115001 | K190802 | 000 |
| 00841436114974 | K190802 | 000 |
| 00841436114950 | K190802 | 000 |
| 00841436114936 | K190802 | 000 |
| 00841436114912 | K190802 | 000 |
| 00841436114882 | K190802 | 000 |
| 00841436114868 | K190802 | 000 |
| 00841436120630 | K190802 | 000 |
| 00841436120623 | K190802 | 000 |
| 00841436120609 | K190802 | 000 |
| 00841436120586 | K190802 | 000 |
| 10841436120897 | K190802 | 000 |
| 00841436120449 | K190802 | 000 |
| 00841436120913 | K190802 | 000 |