Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System
FDA 510(k) K990400 · Hewlett-Packard Co.
510(k) numberK990400
Submission
- Device name
- Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- February 9, 1999
- Decision date
- February 24, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System cleared by the FDA?
Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System (K990400) received a 510(k) decision of Substantially Equivalent on February 24, 1999, 15 days after the submission was received.
What is the product code of K990400?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.