The following data is part of a premarket notification filed by Custom Ultrasonics, Inc. with the FDA for System 83 Plus Washer/disinfector.
| Device ID | K173590 |
| 510k Number | K173590 |
| Device Name: | System 83 Plus Washer/Disinfector |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | Custom Ultrasonics, Inc. 144 Railroad Drive Ivyland, PA 18974 |
| Contact | Mario P. Infanti |
| Correspondent | Mario P. Infanti Custom Ultrasonics, Inc. 144 Railroad Drive Ivyland, PA 18974 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-21 |
| Decision Date | 2020-03-30 |
| Summary: | summary |