HP Sonos 100 CF Ultrasound Imaging System
FDA 510(k) K922184 · Hewlett-Packard Co.
510(k) numberK922184
Submission
- Device name
- HP Sonos 100 CF Ultrasound Imaging System
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- May 11, 1992
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was HP Sonos 100 CF Ultrasound Imaging System cleared by the FDA?
HP Sonos 100 CF Ultrasound Imaging System (K922184) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 80 days after the submission was received.
What is the product code of K922184?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.