The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Non-pyrogenic Ultrasound Transducer Cover.
| Device ID | K131528 |
| 510k Number | K131528 |
| Device Name: | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Contact | Amanda Stahle |
| 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 | 2013-05-28 |
| Decision Date | 2013-06-11 |
| Summary: | summary |