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FDA 510(k)

DSP100 AMPLIFIER

K-Number: K860814 · 1986-12-05

ApplicantIntl. Acoustics, Inc.
Decision Date1986-12-05
Product CodeDQC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DSP100 AMPLIFIER 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 1986-12-05 under 510(k) number K860814. 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 AMPLIFIER?

DSP100 AMPLIFIER is a medical device that received FDA 510(k) clearance on 1986-12-05. The listed applicant is Intl. Acoustics, Inc.. The 510(k) number is K860814.

When did DSP100 AMPLIFIER receive FDA 510(k) clearance?

DSP100 AMPLIFIER received FDA 510(k) clearance on 1986-12-05, under 510(k) number K860814.

Who is the listed applicant for DSP100 AMPLIFIER?

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 AMPLIFIER?

The FDA product code for DSP100 AMPLIFIER 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.

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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 SYSTEMK864429DSP100 CAROTID PHONOANGIOGRAPHY MODULEK844997IAI 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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