The following data is part of a premarket notification filed by Oec-diasonics, Inc. with the FDA for Angioplus-s.
| Device ID | K843972 |
| 510k Number | K843972 |
| Device Name: | ANGIOPLUS-S |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | OEC-DIASONICS, INC. 2341 SOUTH 2300 WEST P.O. BOX 25296 Salt Lake City, UT 84119 |
| Contact | John W Tolhurst |
| Correspondent | John W Tolhurst OEC-DIASONICS, INC. 2341 SOUTH 2300 WEST P.O. BOX 25296 Salt Lake City, UT 84119 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1985-01-03 |