CFM-800 Color Flow Mapping System
FDA 510(k) K924079 · Diasonics, Inc.
510(k) numberK924079
Submission
- Device name
- CFM-800 Color Flow Mapping System
- Applicant
- Diasonics, Inc.
Milipitas, CA, US - Received
- August 13, 1992
- Decision date
- September 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was CFM-800 Color Flow Mapping System cleared by the FDA?
CFM-800 Color Flow Mapping System (K924079) received a 510(k) decision of Substantially Equivalent on September 28, 1993, 411 days after the submission was received.
What is the product code of K924079?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.