The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for General Purpose Latex Transducer Covers.
| Device ID | K970515 |
| 510k Number | K970515 |
| Device Name: | GENERAL PURPOSE LATEX TRANSDUCER COVERS |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 102 1ST ST. SOUTH Kalona, IA 52247 |
| Contact | J. William Jones |
| Correspondent | J. William Jones CIVCO MEDICAL INSTRUMENTS CO., INC. 102 1ST 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 | 1997-02-11 |
| Decision Date | 1997-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436110273 | K970515 | 000 |
| 00841436101486 | K970515 | 000 |
| 00841436101479 | K970515 | 000 |
| 00841436101462 | K970515 | 000 |
| 00841436101455 | K970515 | 000 |
| 00841436110310 | K970515 | 000 |
| 00841436110198 | K970515 | 000 |
| 00841436110181 | K970515 | 000 |
| 00841436104685 | K970515 | 000 |
| 00841436103596 | K970515 | 000 |
| 00841436103589 | K970515 | 000 |
| 00841436103572 | K970515 | 000 |
| 00841436102322 | K970515 | 000 |
| 00841436101523 | K970515 | 000 |
| 00841436100151 | K970515 | 000 |
| 00841436101332 | K970515 | 000 |
| 00841436101349 | K970515 | 000 |
| 00841436110266 | K970515 | 000 |
| 00841436110242 | K970515 | 000 |
| 00841436104791 | K970515 | 000 |
| 00841436104142 | K970515 | 000 |
| 00841436104135 | K970515 | 000 |
| 00841436104128 | K970515 | 000 |
| 00841436103664 | K970515 | 000 |
| 00841436103657 | K970515 | 000 |
| 00841436103633 | K970515 | 000 |
| 00841436101677 | K970515 | 000 |
| 00841436101448 | K970515 | 000 |
| 00841436101431 | K970515 | 000 |
| 00841436101424 | K970515 | 000 |
| 00841436101516 | K970515 | 000 |