The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Occular Compu-scan.
Device ID | K790023 |
510k Number | K790023 |
Device Name: | OCCULAR COMPU-SCAN |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | STORZ INSTRUMENT CO. 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 | 1979-01-03 |
Decision Date | 1979-02-12 |