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 |