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 |