Submission Details
| 510(k) Number | K050601 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 2005 |
| Decision Date | April 15, 2005 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
K050601 - SMARTDOP 45 VASCULAR DOPPLER
(FDA 510(k) Clearance)
Apr 2005
Decision
37d
Days
Class 2
Risk
K050601 is an FDA 510(k) clearance for the SMARTDOP 45 VASCULAR DOPPLER, a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW), submitted by Koven Technology, Inc. (Houston, US). The FDA issued a Cleared decision on April 15, 2005, 37 days after receiving the submission on March 9, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 870.2100.
Device Classification
| Product Code | DPW — Flowmeter, Blood, Cardiovascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2100 |
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