Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES

K-Number: K863372 · 1986-11-04

ApplicantInterspec, Inc.
Decision Date1986-11-04
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Interspec, Inc.. It received FDA 510(k) clearance on 1986-11-04 under 510(k) number K863372. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES?

SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES is a medical device that received FDA 510(k) clearance on 1986-11-04. The listed applicant is Interspec, Inc.. The 510(k) number is K863372.

When did SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES receive FDA 510(k) clearance?

SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES received FDA 510(k) clearance on 1986-11-04, under 510(k) number K863372.

Who is the listed applicant for SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES?

The FDA 510(k) record lists Interspec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES?

The FDA product code for SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES is DPT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Interspec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K940671INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETERK924231INTERSPEC APOGEE CLAK915696INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDEK920678ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETERK911073PROBE REFILL KITK910049INTERSPEC APOGEE, MODIFICATION

View all 17 devices →

Related Devices (Code: DPT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233076Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd.K163339SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0Spectralmd, Inc.K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imagerMoor Instruments, Ltd.K124049DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEMSpectralmd, Inc.K123216AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE ANAimago SAK122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑