The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Ultrasound Transducer Assembly.
Device ID | K862211 |
510k Number | K862211 |
Device Name: | ULTRASOUND TRANSDUCER ASSEMBLY |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 69 SPRING ST. Ramsey, NJ 07446 |
Contact | Raymond F Chase |
Correspondent | Raymond F Chase JOHNSON & JOHNSON PROFESSIONALS, INC. 69 SPRING ST. Ramsey, NJ 07446 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-10 |
Decision Date | 1987-01-02 |