510(k) K954397 ยท DPW Flowmeter, Blood, Cardiovascular
BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY
| Applicant | Koven Technology, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 29, 1996 |
| Received | Sep 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Koven Technology, Inc. Brand Name: BiDop 3
Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe
Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe).
Software Version: N/A
Product Des Open, Classified |
DPW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.