BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY— 510(k) K954397
Substantially EquivalentKoven Technology, Inc.
FDA 510(k) clearance K954397 for BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY, Substantially Equivalent on 1996-03-29. Applicant: Koven Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Koven Technology, Inc.
- Product code
- Code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code DPW
view allMore clearances from Koven Technology, Inc.
view allRecalls naming K954397
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954397.
Data sourced from openFDA. This site is unofficial and independent of the FDA.