Bladdermanager Pci 5000 Model 1002
FDA 510(k) K982568 · Diagnostic Ultrasound Corp.
510(k) numberK982568
Submission
- Device name
- Bladdermanager Pci 5000 Model 1002
- Applicant
- Diagnostic Ultrasound Corp.
Redmond, WA, US - Received
- July 23, 1998
- Decision date
- January 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Bladdermanager Pci 5000 Model 1002 cleared by the FDA?
Bladdermanager Pci 5000 Model 1002 (K982568) received a 510(k) decision of Substantially Equivalent on January 25, 1999, 186 days after the submission was received.
What is the product code of K982568?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.