The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Bladdermanager Pci 5000 Model 1002.
| Device ID | K982568 |
| 510k Number | K982568 |
| Device Name: | BLADDERMANAGER PCI 5000 MODEL 1002 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. 18109 NE 76TH ST. Redmond, WA 98052 |
| Contact | Gerald Mcmorrow |
| Correspondent | Gerald Mcmorrow DIAGNOSTIC ULTRASOUND CORP. 18109 NE 76TH ST. Redmond, WA 98052 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-23 |
| Decision Date | 1999-01-25 |
| Summary: | summary |