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FDA 510(k)

M & R DISPOSABLE ELECTRODE (14200)

K-Number: K963236 · 1996-11-15

ApplicantM & R Mfg., Inc.
Decision Date1996-11-15
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

M & R DISPOSABLE ELECTRODE (14200) is the device name listed in this FDA 510(k) record. The listed applicant is M & R Mfg., Inc.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K963236. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M & R DISPOSABLE ELECTRODE (14200)?

M & R DISPOSABLE ELECTRODE (14200) is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is M & R Mfg., Inc.. The 510(k) number is K963236.

When did M & R DISPOSABLE ELECTRODE (14200) receive FDA 510(k) clearance?

M & R DISPOSABLE ELECTRODE (14200) received FDA 510(k) clearance on 1996-11-15, under 510(k) number K963236.

Who is the listed applicant for M & R DISPOSABLE ELECTRODE (14200)?

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

What is the FDA product code for M & R DISPOSABLE ELECTRODE (14200)?

The FDA product code for M & R DISPOSABLE ELECTRODE (14200) is GXY.

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 M & R Mfg., 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.

K963125M AND R REUSABLE ELECTRODES (MULTIPLE)

Related Devices (Code: GXY)

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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Official Source

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