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FDA 510(k)

PRINTER, DIGITAL

K-Number: K781115 · 1978-10-06

ApplicantOutput, Inc.
Decision Date1978-10-06
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRINTER, DIGITAL is the device name listed in this FDA 510(k) record. The listed applicant is Output, Inc.. It received FDA 510(k) clearance on 1978-10-06 under 510(k) number K781115. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRINTER, DIGITAL?

PRINTER, DIGITAL is a medical device that received FDA 510(k) clearance on 1978-10-06. The listed applicant is Output, Inc.. The 510(k) number is K781115.

When did PRINTER, DIGITAL receive FDA 510(k) clearance?

PRINTER, DIGITAL received FDA 510(k) clearance on 1978-10-06, under 510(k) number K781115.

Who is the listed applicant for PRINTER, DIGITAL?

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 PRINTER, DIGITAL?

The FDA product code for PRINTER, DIGITAL is DSF.

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 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.

K800360OUTPUT DIGITAL DISPLAY MODULE, MOD. 611K780356OUTPUT DIGITAL DISPLAY MODULE, MODEL 401K770987NERVE STIMULATOR, MOLEL NO. FB-800K760614PERIPHERAL NERVE STIMULATOR

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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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