SM-20 Cardioscan Doppler Option with CFM700 Probes
FDA 510(k) K863372 · Interspec, Inc.
510(k) numberK863372
Submission
- Device name
- SM-20 Cardioscan Doppler Option with CFM700 Probes
- Applicant
- Interspec, Inc.
Conshohocken, PA, US - Received
- September 2, 1986
- Decision date
- November 4, 1986
- 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 |
|---|---|---|
| K940671 | Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound FlowmeterITX · Traditional | 11/22/1994SE |
| K924231 | Interspec Apogee ClaIYO · Traditional | 06/14/1993SE |
| K915696 | Interspec Apogee Endo-V Probe and Needle GuideITX · Traditional | 11/24/1992SE |
| K920678 | Ultrasound Imagaing System and Doppler FlowmeterITX · Traditional | 04/02/1992SE |
| K911073 | Probe Refill KitITX · Traditional | 06/06/1991SE |
| K910049 | Interspec Apogee, ModificationDPW · Traditional | 04/29/1991SE |
| K903839 | Interspec ApogeeDXK · Traditional | 11/16/1990SE |
| K900155 | Interspec 2 MHZ, Transcranial Pulsed Wave DopplerITX · Traditional | 10/05/1990SE |
| K892944 | Interspec Transesophageal Probe Model 4515JOP · Traditional | 07/19/1989SE |
| K890173 | Interspec ApogeeIYO · Traditional | 04/14/1989SE |
Questions and answers
When was SM-20 Cardioscan Doppler Option with CFM700 Probes cleared by the FDA?
SM-20 Cardioscan Doppler Option with CFM700 Probes (K863372) received a 510(k) decision of Substantially Equivalent on November 4, 1986, 63 days after the submission was received.
What is the product code of K863372?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.