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FDA 510(k)

SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M

K-Number: K960754 · 1996-09-18

ApplicantMecta Corp.
Decision Date1996-09-18
Product CodeQGH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M is the device name listed in this FDA 510(k) record. The listed applicant is Mecta Corp.. It received FDA 510(k) clearance on 1996-09-18 under 510(k) number K960754. The device is classified under product code QGH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M?

SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M is a medical device that received FDA 510(k) clearance on 1996-09-18. The listed applicant is Mecta Corp.. The 510(k) number is K960754.

When did SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M receive FDA 510(k) clearance?

SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M received FDA 510(k) clearance on 1996-09-18, under 510(k) number K960754.

Who is the listed applicant for SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M?

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

What is the FDA product code for SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M?

The FDA product code for SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M is QGH.

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 Mecta Corp. 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.

K965070SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.K852069MECTA ECT DEVICE MODELS SR & JR

Related Devices (Code: QGH)

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.

K192834MECTA SigmaMecta CorporationK965070SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp.K945120THYMATRON 2000 ELECTROCONVULSIVE SYSTEMSomatics, Inc.K911144MF-500, MODIFICATIONElcot, Inc.K863815ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000Elcot, Inc.K860467ELECTROSHOCK UNIT NEUROLOGY MODEL B-25Medcraft 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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