Bio-Probe System-Blood Flow Probe
FDA 510(k) K830858 · Bio Medicus, Inc.
510(k) numberK830858
Submission
- Device name
- Bio-Probe System-Blood Flow Probe
- Applicant
- Bio Medicus, Inc.
Mchenry, IL, US - Received
- March 17, 1983
- Decision date
- June 8, 1983
- 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 |
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|---|---|---|
| K920761 | Urine Cultur Stabilization Transport TubeLIO · Traditional | 06/19/1992SE |
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| K901253 | (PBS) Portable Bypass System, Model 1000DTZ · Traditional | 09/05/1990SE |
| K901584 | Bio-Medicus Bio Console Models 540 a B CDWA · Traditional | 06/28/1990SE |
| K894980 | Bio-Cal 370 Heater/CoolerDWJ · Traditional | 11/02/1989SE |
| K884129 | Bio-Medicus Percutaneous Cannula & Introducer SetDQY · Traditional | 12/21/1988SE |
| K883956 | Bio-Medicus Tubing ConnectorsDTL · Traditional | 10/28/1988SE |
| K872033 | Bio-Medicus Cannula-TubingDWF · Traditional | 12/07/1987SE |
| K861096 | Cardiopulmonary Cannula TubingDWF · Traditional | 05/21/1986SE |
| K854133 | Bio Medicus Bio Console 540DWA · Traditional | 01/08/1986SE |
Questions and answers
When was Bio-Probe System-Blood Flow Probe cleared by the FDA?
Bio-Probe System-Blood Flow Probe (K830858) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 83 days after the submission was received.
What is the product code of K830858?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.