The following data is part of a premarket notification filed by Aptek Ltd. with the FDA for Auto-mate Camera.
Device ID | K803157 |
510k Number | K803157 |
Device Name: | AUTO-MATE CAMERA |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | APTEK LTD. 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 | 1980-12-04 |
Decision Date | 1981-02-02 |