The following data is part of a premarket notification filed by Phoenix Imaging with the FDA for Resubmitted Ai 5200 Ultrasound Transducer.
| Device ID | K883845 |
| 510k Number | K883845 |
| Device Name: | RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER |
| Classification | Echocardiograph |
| Applicant | PHOENIX IMAGING 4666 SOUTH ASH AVE. Tempe, AZ 85282 |
| Contact | Michael Parsons |
| Correspondent | Michael Parsons PHOENIX IMAGING 4666 SOUTH ASH AVE. Tempe, AZ 85282 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-12 |
| Decision Date | 1989-02-03 |