Laserflo Blood Perfusion Single Use Probes Models SUP-440, SUPR-434 SUP-433
FDA 510(k) K951832 · Vasamedics, LLC
510(k) numberK951832
Submission
- Device name
- Laserflo Blood Perfusion Single Use Probes Models SUP-440, SUPR-434 SUP-433
- Applicant
- Vasamedics, LLC
Saint Paul, MN, US - Received
- April 20, 1995
- Decision date
- March 21, 1996
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K962700 | Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring…DPT · Traditional | 04/09/1997SE |
| K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe KitDPT · Traditional | 10/11/1996SESK |
| K951486 | Model PV2000 Vascular MicrolaboratoryDPW · Traditional | 06/29/1995SE |
| K912446 | Modif. Laserflo Blood Perfusion Monitor Model BPM2DPW · Traditional | 12/12/1991SE |
| K911763 | Laserflo(R) Blood Perfusion Monitor (Model BPM2)DPW · Traditional | 08/13/1991SE |
Questions and answers
When was Laserflo Blood Perfusion Single Use Probes Models SUP-440, SUPR-434 SUP-433 cleared by the FDA?
Laserflo Blood Perfusion Single Use Probes Models SUP-440, SUPR-434 SUP-433 (K951832) received a 510(k) decision of Substantially Equivalent on March 21, 1996, 336 days after the submission was received.
What is the product code of K951832?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.