Bidirectional Doppler W/Waveform Display
FDA 510(k) K954397 · Koven Technology, Inc.
510(k) numberK954397
Submission
- Device name
- Bidirectional Doppler W/Waveform Display
- Applicant
- Koven Technology, Inc.
St. Louis, MO, US - Received
- September 20, 1995
- Decision date
- March 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Bidirectional Doppler W/Waveform Display cleared by the FDA?
Bidirectional Doppler W/Waveform Display (K954397) received a 510(k) decision of Substantially Equivalent on March 29, 1996, 191 days after the submission was received.
What is the product code of K954397?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.