The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for General Purpose Transducer Standoff, Biopsy Transducer Standoff, Bi-plane Endocavity Transducer Standoff.
| Device ID | K992152 |
| 510k Number | K992152 |
| Device Name: | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Contact | J. William Jones |
| Correspondent | J. William Jones 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 | 1999-06-25 |
| Decision Date | 1999-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436109079 | K992152 | 000 |
| 00841436108751 | K992152 | 000 |
| 00841436103725 | K992152 | 000 |
| 00841436103718 | K992152 | 000 |
| 10841436108758 | K992152 | 000 |
| 00841436110280 | K992152 | 000 |
| 00841436104319 | K992152 | 000 |