The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Meridian Ultrasound Imaging System.
Device ID | K853240 |
510k Number | K853240 |
Device Name: | MERIDIAN ULTRASOUND IMAGING SYSTEM |
Classification | Transducer, Ultrasonic |
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 | JOP |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-01 |
Decision Date | 1986-02-21 |