The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Civco/super Scan.
Device ID | K841332 |
510k Number | K841332 |
Device Name: | CIVCO/SUPER SCAN |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-02 |
Decision Date | 1984-05-09 |