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FDA 510(k)

NON-INVASIVE AMPLIFIER

K-Number: K810828 · 1981-04-10

ApplicantHenry Ford Hospital
Decision Date1981-04-10
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NON-INVASIVE AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Henry Ford Hospital. It received FDA 510(k) clearance on 1981-04-10 under 510(k) number K810828. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-INVASIVE AMPLIFIER?

NON-INVASIVE AMPLIFIER is a medical device that received FDA 510(k) clearance on 1981-04-10. The listed applicant is Henry Ford Hospital. The 510(k) number is K810828.

When did NON-INVASIVE AMPLIFIER receive FDA 510(k) clearance?

NON-INVASIVE AMPLIFIER received FDA 510(k) clearance on 1981-04-10, under 510(k) number K810828.

Who is the listed applicant for NON-INVASIVE AMPLIFIER?

The FDA 510(k) record lists Henry Ford Hospital as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-INVASIVE AMPLIFIER?

The FDA product code for NON-INVASIVE AMPLIFIER is DRR.

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Related Devices (Code: DRR)

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.

K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.K925346EP AMP, MODEL #901Quinton Electrophysiology Corp.K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.K910307CARDIOLAB AMPLIFIER MODULE (CAM)Prucka Engineering, Inc.

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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