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FDA 510(k)

THYMATRON 2000 ELECTROCONVULSIVE SYSTEM

K-Number: K945120 · 1995-10-26

ApplicantSomatics, Inc.
Decision Date1995-10-26
Product CodeQGH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THYMATRON 2000 ELECTROCONVULSIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Somatics, Inc.. It received FDA 510(k) clearance on 1995-10-26 under 510(k) number K945120. 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 THYMATRON 2000 ELECTROCONVULSIVE SYSTEM?

THYMATRON 2000 ELECTROCONVULSIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-26. The listed applicant is Somatics, Inc.. The 510(k) number is K945120.

When did THYMATRON 2000 ELECTROCONVULSIVE SYSTEM receive FDA 510(k) clearance?

THYMATRON 2000 ELECTROCONVULSIVE SYSTEM received FDA 510(k) clearance on 1995-10-26, under 510(k) number K945120.

Who is the listed applicant for THYMATRON 2000 ELECTROCONVULSIVE SYSTEM?

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

What is the FDA product code for THYMATRON 2000 ELECTROCONVULSIVE SYSTEM?

The FDA product code for THYMATRON 2000 ELECTROCONVULSIVE SYSTEM is QGH.

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Other records listing Somatics, 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.

K992269VENTIL-A ORAL PROTECTORK890711DUAL GRAPH (TM) RECORDER-MONITORK890710DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDSK882809THYMAPADK864181SOMATICS MOUTH GUARD (BITE BLOCK)K843923THYMATRON

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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.K960754SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp.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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