The following data is part of a premarket notification filed by Foley, Lardner, Hollabaugh & Jacobs with the FDA for Sonograf Edp Real-time Adapter.
Device ID | K780578 |
510k Number | K780578 |
Device Name: | SONOGRAF EDP REAL-TIME ADAPTER |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | FOLEY, LARDNER, HOLLABAUGH & JACOBS 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 | 1978-04-10 |
Decision Date | 1978-05-25 |