The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for 5.0 Mhz Meridian Ultrasound Imaging System.
| Device ID | K860009 |
| 510k Number | K860009 |
| Device Name: | 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM |
| 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 | 1986-01-03 |
| Decision Date | 1986-08-20 |