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FDA 510(k)

MA-400 EMB FEEDBACK DEVICE

K-Number: K853806 · 1985-12-10

ApplicantSpectral Data Systems
Decision Date1985-12-10
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MA-400 EMB FEEDBACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Data Systems. It received FDA 510(k) clearance on 1985-12-10 under 510(k) number K853806. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MA-400 EMB FEEDBACK DEVICE?

MA-400 EMB FEEDBACK DEVICE is a medical device that received FDA 510(k) clearance on 1985-12-10. The listed applicant is Spectral Data Systems. The 510(k) number is K853806.

When did MA-400 EMB FEEDBACK DEVICE receive FDA 510(k) clearance?

MA-400 EMB FEEDBACK DEVICE received FDA 510(k) clearance on 1985-12-10, under 510(k) number K853806.

Who is the listed applicant for MA-400 EMB FEEDBACK DEVICE?

The FDA 510(k) record lists Spectral Data Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MA-400 EMB FEEDBACK DEVICE?

The FDA product code for MA-400 EMB FEEDBACK DEVICE is HCC.

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 Spectral Data Systems 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.

K832146TA-400 TEMP. FEEDBACK DEVICE

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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