Diagnostic Ultrasound Versadopp 1000
FDA 510(k) K904792 · Diagnostic Ultrasound Corp.
510(k) numberK904792
Submission
- Device name
- Diagnostic Ultrasound Versadopp 1000
- Applicant
- Diagnostic Ultrasound Corp.
Kirkland, WA, US - Received
- October 23, 1990
- Decision date
- January 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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Questions and answers
When was Diagnostic Ultrasound Versadopp 1000 cleared by the FDA?
Diagnostic Ultrasound Versadopp 1000 (K904792) received a 510(k) decision of Substantially Equivalent on January 28, 1991, 97 days after the submission was received.
What is the product code of K904792?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.