The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Us-1000 Ultrasonic Imaging System.
Device ID | K832331 |
510k Number | K832331 |
Device Name: | US-1000 ULTRASONIC IMAGING SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | NIDEK, 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 | 1983-07-18 |
Decision Date | 1983-08-16 |