The following data is part of a premarket notification filed by Electra-physics Laboratories, Inc. with the FDA for Litton 300l Ultrasound System.
Device ID | K770999 |
510k Number | K770999 |
Device Name: | LITTON 300L ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | ELECTRA-PHYSICS LABORATORIES, 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 | 1977-06-02 |
Decision Date | 1978-01-12 |