The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Ms-50 Ultrasonic Imager.
Device ID | K811252 |
510k Number | K811252 |
Device Name: | MS-50 ULTRASONIC IMAGER |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | KONTRON INSTRUMENTS, 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 | 1981-05-05 |
Decision Date | 1981-08-07 |