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FDA 510(k)

DSP100 CAROTID PHONOANGIOGRAPHY MODULE

K-Number: K864429 · 1987-05-12

ApplicantIntl. Acoustics, Inc.
Decision Date1987-05-12
Product CodeDQC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DSP100 CAROTID PHONOANGIOGRAPHY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Acoustics, Inc.. It received FDA 510(k) clearance on 1987-05-12 under 510(k) number K864429. The device is classified under product code DQC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSP100 CAROTID PHONOANGIOGRAPHY MODULE?

DSP100 CAROTID PHONOANGIOGRAPHY MODULE is a medical device that received FDA 510(k) clearance on 1987-05-12. The listed applicant is Intl. Acoustics, Inc.. The 510(k) number is K864429.

When did DSP100 CAROTID PHONOANGIOGRAPHY MODULE receive FDA 510(k) clearance?

DSP100 CAROTID PHONOANGIOGRAPHY MODULE received FDA 510(k) clearance on 1987-05-12, under 510(k) number K864429.

Who is the listed applicant for DSP100 CAROTID PHONOANGIOGRAPHY MODULE?

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

What is the FDA product code for DSP100 CAROTID PHONOANGIOGRAPHY MODULE?

The FDA product code for DSP100 CAROTID PHONOANGIOGRAPHY MODULE is DQC.

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 Intl. Acoustics, 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.

K873640MODIFIED DSP100 AMPLIFIERK864278DS-II DIGITAL SONOGRAPHY SYSTEMK860814DSP100 AMPLIFIERK844997IAI PROGRAM-COMPUTER PROGRAM

Related Devices (Code: DQC)

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.

K950537CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPHCardiophonics, Inc.K952651LIFE SOUND SENSORFlowscan, Inc.K943726ACOUSTIC RECORDERTechnology Applications Assoc., Inc.K924054PHONOCARDIOGRAPHEcho UltrasoundK902185DYNAMIC SPECTRAL PHONOCARDIOGRAPHReeves Scientific, Inc.K900560ACUSON HEARTSOUND/PULSE/RESPIRATION MODULEAcuson Corp.

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.

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