The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Auto Sector Mcu.
Device ID | K813596 |
510k Number | K813596 |
Device Name: | AUTO SECTOR MCU |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | TECHNICARE CORP. 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 | 1981-12-28 |
Decision Date | 1982-03-25 |