The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Synthetic Polysioprene Ultrasound Transducer Cover.
| Device ID | K013721 |
| 510k Number | K013721 |
| Device Name: | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Contact | Theresa Leinen |
| Correspondent | Theresa Leinen CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. 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 | 2001-11-09 |
| Decision Date | 2001-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436111720 | K013721 | 000 |
| 00841436110297 | K013721 | 000 |
| 00841436104524 | K013721 | 000 |
| 00841436104265 | K013721 | 000 |
| 00841436104258 | K013721 | 000 |
| 00841436104180 | K013721 | 000 |
| 00841436104173 | K013721 | 000 |
| 00841436104166 | K013721 | 000 |
| 00841436102162 | K013721 | 000 |
| 00841436101929 | K013721 | 000 |
| 00841436101806 | K013721 | 000 |
| 00841436101493 | K013721 | 000 |
| 00841436110341 | K013721 | 000 |
| 00841436110358 | K013721 | 000 |
| 00841436111713 | K013721 | 000 |
| 00841436110303 | K013721 | 000 |
| 00841436107273 | K013721 | 000 |
| 00841436104210 | K013721 | 000 |
| 00841436104203 | K013721 | 000 |
| 00841436104197 | K013721 | 000 |
| 00841436102179 | K013721 | 000 |
| 00841436101813 | K013721 | 000 |
| 00841436111386 | K013721 | 000 |
| 00841436110372 | K013721 | 000 |
| 00841436110365 | K013721 | 000 |
| 00841436121651 | K013721 | 000 |