Bio-Probe Transducer (Adult)
FDA 510(k) K133903 · Medtronic, Inc.
510(k) numberK133903
Submission
- Device name
- Bio-Probe Transducer (Adult)
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- December 20, 2013
- Decision date
- April 10, 2014
- 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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| K163339 | Spectralmd Deepview Wound Imaging System 2.0DPT · Traditional | Spectralmd, Inc. | 08/17/2017SE |
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| K132730 | Bio-Probe Disposable Insert with; Balance Biosurface, Carmeda Bioactive Surface…DPT · Traditional | Medtronic, Inc. | 05/30/2014SE |
| 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 |
| K121429 | Aimago Easyldi Microcirculation CameraDPT · Traditional | Aimago SA | 08/10/2012SE |
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Questions and answers
When was Bio-Probe Transducer (Adult) cleared by the FDA?
Bio-Probe Transducer (Adult) (K133903) received a 510(k) decision of Substantially Equivalent on April 10, 2014, 111 days after the submission was received.
What is the product code of K133903?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.