The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Model Ust-ssd 880l1-5 Tranesophageal Phased Array.
| Device ID | K861710 |
| 510k Number | K861710 |
| Device Name: | MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY |
| Classification | Echocardiograph |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 69 SPRING ST. Ramsey, NJ 07446 |
| Contact | Raymond Chase |
| Correspondent | Raymond Chase JOHNSON & JOHNSON PROFESSIONALS, INC. 69 SPRING ST. Ramsey, NJ 07446 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-05 |
| Decision Date | 1986-07-09 |