K073593 is an FDA 510(k) clearance for the I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016. This device is classified as a Probe, Blood-flow, Extravascular (Class II - Special Controls, product code DPT).
Submitted by Deltex Medical Limited (Stevenage, Hertfordshire, GB). The FDA issued a Cleared decision on January 29, 2009, 405 days after receiving the submission on December 21, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2120.
| 510(k) Number | K073593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2007 |
| Decision Date | January 29, 2009 |
| Days to Decision | 405 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPT — Probe, Blood-flow, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2120 |