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FDA 510(k)

OUTPUT DIGITAL DISPLAY MODULE, MOD. 611

K-Number: K800360 · 1980-02-29

ApplicantOutput, Inc.
Decision Date1980-02-29
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 is the device name listed in this FDA 510(k) record. The listed applicant is Output, Inc.. It received FDA 510(k) clearance on 1980-02-29 under 510(k) number K800360. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OUTPUT DIGITAL DISPLAY MODULE, MOD. 611?

OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 is a medical device that received FDA 510(k) clearance on 1980-02-29. The listed applicant is Output, Inc.. The 510(k) number is K800360.

When did OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 receive FDA 510(k) clearance?

OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 received FDA 510(k) clearance on 1980-02-29, under 510(k) number K800360.

Who is the listed applicant for OUTPUT DIGITAL DISPLAY MODULE, MOD. 611?

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

What is the FDA product code for OUTPUT DIGITAL DISPLAY MODULE, MOD. 611?

The FDA product code for OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 is DSK.

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 Output, 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.

K781115PRINTER, DIGITALK780356OUTPUT DIGITAL DISPLAY MODULE, MODEL 401K770987NERVE STIMULATOR, MOLEL NO. FB-800K760614PERIPHERAL NERVE STIMULATOR

Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, 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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