BV105 (&BV105R) Vascular Flow Detector W/Optional
FDA 510(k) K873673 · Sonicaid, Inc.
510(k) numberK873673
Submission
- Device name
- BV105 (&BV105R) Vascular Flow Detector W/Optional
- Applicant
- Sonicaid, Inc.
Clearwater, FL, US - Received
- September 11, 1987
- Decision date
- February 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K872074 | 5 MHZ TransducerJOP · Traditional | 08/25/1987SE |
| K863803 | Vasopulse(Tm)/Model 5000JOM · Traditional | 05/06/1987SE |
| K862720 | VASOFLO-3 & Extravascular Blood Flow ProbesDPW · Traditional | 11/17/1986SE |
| K861237 | Vasoview Duplex Imaging SystemITX · Traditional | 07/14/1986SN |
| K851102 | Vasoscreen Impedance PlethysmographDQB · Traditional | 05/16/1985SE |
| K833902 | VasoscanJOP · Traditional | 01/27/1984SE |
| K832374 | Photoflo Dual-Mode PhotoplethysmographJOM · Traditional | 12/01/1983SE |
| K833488 | SonicompHEM · Traditional | 11/28/1983SE |
| K833227 | Sonicaid Model D206E Air Emboli-DetectLBA · Traditional | 10/27/1983SE |
| K831371 | Model FM5HGM · Traditional | 06/30/1983SE |
Questions and answers
When was BV105 (&BV105R) Vascular Flow Detector W/Optional cleared by the FDA?
BV105 (&BV105R) Vascular Flow Detector W/Optional (K873673) received a 510(k) decision of Substantially Equivalent on February 26, 1988, 168 days after the submission was received.
What is the product code of K873673?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.