I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015, 9090-7016
FDA 510(k) K073593 · Deltex Medical Limited
510(k) numberK073593
Submission
- Device name
- I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015, 9090-7016
- Applicant
- Deltex Medical Limited
Stevenage, Hertfordshire, GB - Received
- December 21, 2007
- Decision date
- January 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2120
- Specialty
- Cardiovascular
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|---|---|---|---|
| K233076 | Laser Speckle Imaging System (RFLSI CZW)DPT · Traditional | Rwd Life Science Co., Ltd. | 05/28/2024SE |
| K163339 | Spectralmd Deepview Wound Imaging System 2.0DPT · Traditional | Spectralmd, Inc. | 08/17/2017SE |
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser…DPT · Traditional | Moor Instruments, Ltd. | 05/12/2016SE |
| K142932 | Deltex Medical KDP72 Doppler ProbeDPT · Traditional | Deltex Medical Limited | 01/22/2015SE |
| K132730 | Bio-Probe Disposable Insert with; Balance Biosurface, Carmeda Bioactive Surface…DPT · Traditional | Medtronic, Inc. | 05/30/2014SE |
| K133903 | Bio-Probe Transducer (Adult)DPT · Traditional | Medtronic, Inc. | 04/10/2014SE |
| K132163 | Moorldls-Bi Laser Doppler Burns ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/29/2014SE |
| K124049 | Deepview Digital Video Physiological Portable Imaging SystemDPT · Traditional | Spectralmd, Inc. | 04/18/2013SE |
| K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…DPT · Traditional | Aimago SA | 02/07/2013SE |
| K122943 | MOORFLPI-2 Full-Field Laser Perfusion ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/03/2013SE |
More from Moor Instruments, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDPW · Traditional | 06/28/2018SE |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+DPW · Traditional | 07/24/2015SE |
| K142932 | Deltex Medical KDP72 Doppler ProbeDPT · Traditional | 01/22/2015SE |
| K132139 | Deltex Medical Cardioq-Edm+DPW · Traditional | 10/10/2013SE |
| K111542 | Deltex Medical Cardioq EdmDPW · Traditional | 10/20/2011SE |
| K052989 | DP240 240 Hour Doppler ProbeDPT · Traditional | 03/08/2006SE |
| K031706 | Cardioq, Model 9051-7005DPW · Traditional | 08/06/2003SE |
| K951369 | EdmDPW · Traditional | 11/07/1995SE |
Questions and answers
When was I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015, 9090-7016 cleared by the FDA?
I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015, 9090-7016 (K073593) received a 510(k) decision of Substantially Equivalent on January 29, 2009, 405 days after the submission was received.
What is the product code of K073593?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.